Respironics, Inc.

• Litetouch Small Mask Ref 1082714

  Class I EUDAMEDFDA UDI Active

• Magneto Nasal Mask Ref K210386

  Class II FDA 510(k) Active

• Respironics Protecteasy Ref K863171

  Class I FDA 510(k) Active

• Virtuoso Lx Smart Cpap System Ref K993433

  Class II FDA 510(k) Active

• Stick-On Disposable Nasal Mask, Model 312174, 1001964 Ref K990574

  Class II FDA 510(k) Active

• Care Orchestrator Essence Ref K183226

  Class II FDA 510(k) Active

• IMAGE3 Se Disposable Full Face Mask Ref K023135

  Class II FDA 510(k) Active

• Performax Pediatric Se Total Face Mask Ref K120639

  Class II FDA 510(k) Active

• Bipap Pro 2 Bi-Level System With Bi-Flex Ref K043607

  Class II FDA 510(k) Active

• Trilogy 200 Ventilator Ref K093416

  Class II FDA 510(k) Active

• Bipap Autosv Ref K063540

  Class II FDA 510(k) Active

• Remstar Auto A-Flex Ht Ref K113068

  Class II FDA 510(k) Active

• Bipap Synchrony Hc Ref K992530

  Class II FDA 510(k) Active

• Monarch Ii Mini Mask Ref K992336

  Class II FDA 510(k) Active

• Quartet Clinical System Ref K963761

  Class II FDA 510(k) Active

• Smartmonitor 2 Professional Series (Ps) Ref K032403

  Class II FDA 510(k) Active

• Sidestream Plus Ref K062689

  Class II FDA 510(k) Active

• Trilogy 202 Ventilator Ref K093905

  Class II FDA 510(k) Active

• Remstar Pro M-Series Cpap & Heated Humidifier System Ref K072996

  Class II FDA 510(k) Active

• Respironics Sleepeasy Cpap System Ref K091112

  Class II FDA 510(k) Active

• Plix Ref K050414

  Class II FDA 510(k) Active

• Solo Cpap System Ref K961626

  Class II FDA 510(k) Active

• Humidifier Ref K945782

  Class II FDA 510(k) Active

• Respironics Golox Ref K072723

  Class II FDA 510(k) Active

• Ventilator, Non-continuous (Respirator) Ref K201439

  Class II FDA 510(k) Active

• Remstar Se Ref K130077

  Class II FDA 510(k)FDA UDI Active

• Aria Cpap System Ref K953341

  Class II FDA 510(k) Active

• Respironics Bipap Pressure Alarm (Bipap P.A.) Ref K902276

  Class II FDA 510(k) Active

• Respironics Sanders Bipapeasy Ref K871523

  Class II FDA 510(k) Active

• Respironics Sealeasy Ii Ref K890795

  Class I FDA 510(k) Active

• Bipap Duet Lx Bi-Level System Ref K000994

  Class II FDA 510(k) Active

• Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large Ref K961915

  Class II FDA 510(k) Active

• Remstar Wtih Ramp And Remote Modification Ref K920699

  Class II FDA 510(k) Active

• H2 Heated Humidifier Ref K030090

  Class II FDA 510(k) Active

• Cricket 2000 Recording Pulse Oximeter Ref K972829

  Class II FDA 510(k) Active

• Comfortlite Nasal Mask Ref K082558

  Class II FDA 510(k) Active

• Simple T Youth Nasal Mask Ref K140268

  Class II FDA 510(k) Active

• Respironics Pr Valve Ref K833327

  Class II FDA 510(k) Active

• Respironics Heated Humidifier Ref K012633

  Class II FDA 510(k) Active

• Rescue Valve Ref K833748

  Class II FDA 510(k) Active

• Hayek Oscillator(Tm) Ref K924341

  Class II FDA 510(k) Active

• C2 Nasal Mask Ref K033759

  Class II FDA 510(k) Active

• Rinoflow Micronized E.N.T. Wash System Ref K973875

  Class I FDA 510(k) Active

• SomnaPatch Ref K183625

  Class II FDA 510(k) Active

• Golox-93 Ref K081779

  Class II FDA 510(k) Active

• Trilogy Evo Universal Ref K181170

  Class II FDA 510(k) Active

• Alice 5 Ref K040595

  Class II FDA 510(k) Active

• Respironics Custom Ii Oral Appliance Ref K033823

  Class II FDA 510(k) Active

• Bageasy(R) Iii Adult Disposable Manual Resuscitator Ref K934310

  Class II FDA 510(k) Active

• Gel Mask Ref K954207

  Class II FDA 510(k) Active

Showing the 10 most recent of 54 recalls.

• 2012

  • 27 Apr 2012 Z-2024-2012 Class I Terminated The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.via FDA establishment Respironics, Inc.

• 2011

  • 11 Oct 2011 Z-0296-2012 Unclassified (pre-2012) Terminated Trilogy 100, 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the inside of the blower housing/impeller enclosure. This may impact therapy.via FDA establishment Respironics, Inc.

• 2010

  • 10 Jun 2010 Z-1896-2010 Unclassified (pre-2012) Terminated It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event.via FDA establishment Respironics, Inc.

• 2009

  • 23 Apr 2009 Z-1411-2009 Unclassified (pre-2012) Terminated Audible alarm failure.via FDA establishment Respironics, Inc.
  • 5 Feb 2009 Z-1260-2009 Unclassified (pre-2012) Terminated Malfunction of the J3 connection between the Heater Plate Main printed circuit assembly (PCA) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the humidifier PCA.via FDA establishment Respironics, Inc.

• 2008

  • 8 Jul 2008 Z-2344-2008 Unclassified (pre-2012) Terminated Certain PLV-100 ventilators may not trigger a signal to activate third-party remote alarms or nurse call systems upon device failure.via FDA establishment Respironics, Inc.
  • 8 Jul 2008 Z-2345-2008 Unclassified (pre-2012) Terminated Certain PLV-100 ventilators may not trigger a signal to activate third-party remote alarms or nurse call systems upon device failure.via FDA establishment Respironics, Inc.

• 2007

  • 15 Oct 2007 Z-1055-2008 Unclassified (pre-2012) Terminated Foreign material: Glass fragments may present in the plastic bag material used to ship components.via FDA establishment Respironics, Inc.
  • 15 Oct 2007 Z-1056-2008 Unclassified (pre-2012) Terminated Foreign material: Glass fragments may present in the plastic bag material used to ship components.via FDA establishment Respironics, Inc.
  • 15 Oct 2007 Z-1057-2008 Unclassified (pre-2012) Terminated Foreign material: Glass fragments may present in the plastic bag material used to ship components.via FDA establishment Respironics, Inc.

• Respironics, Inc. Coyol Alajuela · CR FEI 3027553886

Country

United States

Address

1001, Murry Ridge Lane, Murrysville, United States

Website

n/a

Email

[email protected]

Phone

n/a

PRRC contact

Melissa Rosko

EUDAMED SRN

US-MF-000002301

FDA FEI number

3007220521

DUNS number

080728314