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Maquet SAS

Active in EUDAMED

Francefrom SRN EUDAMED FDA SRN FR-MF-000002926

Maquet SAS is a medical device manufacturer based in France, with 3,412 devices listed and 49 FDA recalls as of 14 Nov 2026.

Devices
3,412
Registrations
EUDAMEDFDA
FDA recalls
492 ongoing

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 2,998
  • EUDAMED 2,814

Among the 3,000 best-ranked of 3,412 devices.

Device classes
  • EU Class I 2,664
  • FDA Class II 334
  • FDA Class I 2

Among the 3,000 best-ranked of 3,412 devices.

Top EMDN categories

Among the 3,000 best-ranked of 3,412 devices.

FDA recalls
Identifiers
  • EUDAMED SRN FR-MF-000002926
  • DUNS 264700139

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment, FDA recalls

What Maquet SAS makes

Maquet SAS manufactures operating room light systems, including ceiling-mounted and wall-mounted surgical lights with adjustable brightness and positioning features. Models include fixed and adjustable intensity units, some with integrated controls for surgical precision.

These devices are classified as Class I under EU regulations and are registered in the eudamed database. The company is based in France.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3,412

Newest first, rows 1-50 of 3,412

Search and filter all 3,412 devices
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  • PWDII50SF Vp K3 Xo XHD127 SAX081216 Ref ARD2PWT00391A

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Volista ARDVCS209059A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209061A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209062A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209063A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209066A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209067A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209068A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209069A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209070A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209071A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209074A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209075A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209076A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209079A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209080A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209081A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209085A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS209086A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629118A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629119A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629120A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629124A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629125A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629126A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629127A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629128A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629132A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629130A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629134A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629140A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629142A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629141A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629143A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629145A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629144A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629146A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629149A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629150A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629151A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629152A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629153A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS629155A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS639091A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS639095A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS639092A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS639097A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS639100A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS639099A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Volista ARDVCS639101A Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

Rows 1-50 of 3,412

Showing 1-50 of 3,412

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FR-MF-000002926
DUNS number
264700139
EU VAT number
FR00311844229
EUDAMED status
Active
EUDAMED registered name
Maquet SAS
Registered address
Parc de Limère - Avenue de la Pomme de Pin, 45160, ARDON, France
Phone
+33 6 08 73 60 40
PRRC contact
Léa FRICHE(public in EUDAMED)

FDA recalls49

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 1
  • 2018 2
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 1
  • 2026 1

44 initiated before 2017

Showing the 10 most recent of 49 recalls.

  • 2026

    • 7 Aug 2026 Z-3224-2026 Class II Ongoing The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.via FDA establishment MAQUET GMBH Distribution: US Nationwide distribution. Submission number: K070442

  • 2025

    • 14 Jul 2025 Z-2420-2025 Class II Ongoing Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel.via FDA establishment MAQUET GMBH Distribution: Worldwide - US Nationwide distribution in the states of KY, NY, TX and the countries of Algeria, Australia, Austria,…
      Full distribution text Worldwide - US Nationwide distribution in the states of KY, NY, TX and the countries of Algeria, Australia, Austria, Bulgaria, Canada, China, Colombia, Denmark, Egypt, Estonia, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Lebanon, Morocco, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom.

  • 2018

    • 14 Jun 2018 Z-2502-2018 Class II Terminated Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light head bracket breaking, causing the light head to detach from the arm and become suspended only from the cabling inside the arm. Use of an affected device may result in serious injury to patient and/or medical staff if the light head detaches and drops, impacting patient and/or medical staff during demonstration, service, or use.via FDA establishment MAQUET GMBH Distribution: Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, KS, KY, LA, MD, ME, MO, NE,…
      Full distribution text Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, KS, KY, LA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, and WA. Foreign distribution to Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil Cameroon, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Ghana, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Poland, Portugal, South Korea, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Tanzania, Yemen, and Zimbabwe.
      Submission number: K130513
    • 19 Apr 2018 Z-1937-2018 Class II Terminated Potential keypad failure on VOLISTA StandOP Surgical Lights.via FDA establishment MAQUET GMBH Distribution: Worldwide Distribution: US (nationwide) and countries of: (AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CM, CN, CO, CZ,…
      Full distribution text Worldwide Distribution: US (nationwide) and countries of: (AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CM, CN, CO, CZ, DE, DK, EC, EE, EG, ES, Fl, FR, GB, GH, HK, HR, HU, IE, IN, IQ, IR, IT, JO, JP, KE, KR, LB, LU, LV, MQ, MX, MY, NA, NG, NL, OM, PA, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, TW, TZ, YE, ZA, ZW).
      Submission number: K130513

  • 2017

    • 22 May 2017 Z-0490-2018 Class II Terminated 55 kits were distributed after their expiration date of September 2015.via FDA establishment MAQUET GMBH Distribution: Distributed to the states of NM, CA, and IL. Submission number: K053025

  • 2012

    • 2 Nov 2012 Z-0627-2013 Class II Terminated There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.via FDA establishment MAQUET GMBH Distribution: Worldwide Distribution - USA including AR, GA, SC, TX, TN and internationally to France, United Arab Emirates,…
      Full distribution text Worldwide Distribution - USA including AR, GA, SC, TX, TN and internationally to France, United Arab Emirates, Australia, Brazil, Canada, Switzerland, China, Germany, Spain, United Kingdom, Italy, Japan, Sweden, Thailand, Turkey, Serbia, and South Africa.
    • 29 May 2012 Z-2210-2012 Class II Terminated Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.via FDA establishment MAQUET GMBH Distribution: Worldwide Distribution - USA including MI, MN and Internationally Submission number: K023251

  • 2011

    • 22 Dec 2011 Z-1362-2012 Unclassified (pre-2012) Terminated The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing.via FDA establishment MAQUET GMBH Distribution: USA Nationwide Distribution Submission number: K041223
    • 22 Dec 2011 Z-1363-2012 Unclassified (pre-2012) Terminated The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing.via FDA establishment MAQUET GMBH Distribution: USA Nationwide Distribution Submission number: K041223
    • 19 Sep 2011 Z-0352-2012 Unclassified (pre-2012) Terminated Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24).via FDA establishment MAQUET GMBH Distribution: Nationwide distribution. Submission number: K041223
Show the 25 most recent of 49 recalls

  • 2011

    • 19 Sep 2011 Z-0353-2012 Unclassified (pre-2012) Terminated Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24).via FDA establishment MAQUET GMBH Distribution: Nationwide distribution. Submission number: K041223
    • 19 Sep 2011 Z-0354-2012 Unclassified (pre-2012) Terminated Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24).via FDA establishment MAQUET GMBH Distribution: Nationwide distribution. Submission number: K041223
    • 19 Sep 2011 Z-0389-2012 Unclassified (pre-2012) Terminated A component of the Magnus hybrid OR system fails to respond to a position command.via FDA establishment MAQUET GMBH Distribution: Worldwide Distribution - USA including VA, LA, MO, NC, MD, and AZ and the countries of AE, AU, CA, CH, CN, DE, DK, ES,…
      Full distribution text Worldwide Distribution - USA including VA, LA, MO, NC, MD, and AZ and the countries of AE, AU, CA, CH, CN, DE, DK, ES, IE, IL, SP, PL, RU, and TH.
    • 20 Jun 2011 Z-3057-2011 Unclassified (pre-2012) Terminated HL 20 Consoles for 4-pump and 5-pump configuration can malfunction if an excessive amount of liquid is used causing circuit board malfunction.via FDA establishment MAQUET GMBH Distribution: Nationwide Distribution Submission number: K943803
    • 20 Jun 2011 Z-3084-2011 Unclassified (pre-2012) Terminated Maquet HL 20 Twin Pump Modules may unintentionally increase speeds for a 1.5-2 second period of time before returning to its original speed.via FDA establishment MAQUET GMBH Distribution: Nationwide Distribution Submission number: K943803
    • 20 Apr 2011 Z-2628-2011 Unclassified (pre-2012) Terminated Through customer complaints, Maquet has been informed that SERVO-i ventilators have stopped to ventilate and have generated three different technical error codes.via FDA establishment MAQUET GMBH Distribution: Worldwide Distribution - USA (nationwide)
    • 20 Apr 2011 Z-2629-2011 Unclassified (pre-2012) Terminated Through customer complaints, Maquet has been informed that SERVO-i ventilators have stopped to ventilate and have generated three different technical error codes.via FDA establishment MAQUET GMBH Distribution: Worldwide Distribution - USA (nationwide)
    • 15 Apr 2011 Z-2238-2011 Unclassified (pre-2012) Terminated Maquet GmbH's quality monitoring detected that incorrect cover sheets were installed with some Magnus carbon fibre table tops.via FDA establishment MAQUET GMBH Distribution: LA, MO, VA

  • 2010

    • 7 Sep 2010 Z-0011-2011 Unclassified (pre-2012) Terminated Tubing packs may contain defective 1/2 inch x 1/2 inch tubing connectors. Leaks at the shank of the connector may result in air aspiration in the venous line.via FDA establishment MAQUET GMBH Distribution: Worldwide Distribution: USA State of IL and country of the Netherlands. Submission number: K080592
    • 13 Jul 2010 Z-2401-2010 Unclassified (pre-2012) Terminated The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.via FDA establishment MAQUET GMBH Distribution: Distribution: Pennsylvania Submission number: K053025

  • 2009

    • 17 Nov 2009 Z-0588-2010 Unclassified (pre-2012) Terminated Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.via FDA establishment MAQUET GMBH Distribution: Worldwide distribution Submission numbers: K902859, K970839
    • 17 Nov 2009 Z-0589-2010 Unclassified (pre-2012) Terminated Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.via FDA establishment MAQUET GMBH Distribution: Worldwide distribution Submission numbers: K871254, K884520
    • 22 Oct 2009 Z-0480-2010 Unclassified (pre-2012) Terminated Product monitoring has determined that the connection bracket shows potential mechanical play at the OR table interface for some procedures. This is due to the hole in the lock washer, which is responsible for locking the accessory to the OR table, being too large.via FDA establishment MAQUET GMBH Distribution: Nationwide Distribution -- USA, including states of SC and PA.
    • 7 Oct 2009 Z-0182-2010 Unclassified (pre-2012) Terminated Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm.via FDA establishment MAQUET GMBH Distribution: Nationwide Distribution. Submission number: K895715
    • 7 Oct 2009 Z-0183-2010 Unclassified (pre-2012) Terminated Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm.via FDA establishment MAQUET GMBH Distribution: Nationwide Distribution. Submission number: K895715

FDA establishments2

Registered with the FDA under this company group, matched by name.

  • Maquet GmbH RASTATT Baden-Wurttemberg · DE Other ID 1841
  • Maquet, Inc. US

Frequently asked questions

How many devices does MAQUET SAS have in the registry?

The registry currently lists 3412 devices for MAQUET SAS. Devices recorded under merged duplicate company entries are counted once.

Which registries list MAQUET SAS's devices?

Among its 50 most recently registered devices, MAQUET SAS has devices listed in EUDAMED (50 devices) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do MAQUET SAS's devices fall under?

Among its 50 most recently registered devices, the classes recorded for MAQUET SAS's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for MAQUET SAS?

FDA recall records list 49 recalls initiated by MAQUET SAS, the most recent initiated on 7 Aug 2026. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from MAQUET SAS in the registry?

The most recently registered devices listed for MAQUET SAS include PWDII50SF VP K3 XO XHD127 SAX081216, Volista ARDVCS209059A, Volista ARDVCS209061A and Volista ARDVCS209062A.

Which FDA establishments are linked to MAQUET SAS?

2 FDA establishments are linked to MAQUET SAS in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.