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DigitalDiagnost 4 Flex / Value

by Philips Medical Systems DMC GmbH

Part of a family of 7 devices: see the family page

Ref 712032

DigitalDiagnost 4 Flex / Value (712032) is a device classified as Class IIb in the EU and Class II in the US made by Philips Medical Systems DMC GmbH, registered in EUDAMED on 12 Jun 2024 (Basic UDI-DI 0884838BM440SS), cleared under FDA 510(k) K210692 on 2 Apr 2021 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00884838074514), active as of 25 Oct 2026. 4 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

8 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210692↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM440SS Basic UDI-DI 00884838074514UDI-DIDate12 Jun 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK210692 Date2 Apr 2021IssuedStatusActive
United StatesGUDID listing GUDID Number00884838074514 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0884838BM440SS registered 12 Jun 2024 Active
  • FDA 510(k) K210692 decided 2 Apr 2021 Active
  • FDA GUDID UDI-DI 00884838074514 listed 19 Sep 2016 Listed

Recalls

8 recalls · 8 ongoing · FDA

    • Ongoing Z-0464-2026 FDA Class II initiated 1 Oct 2025

    Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.

  • 5 recalls, same reason

    • Ongoing Z-0274-2024 FDA Class II initiated 21 Sep 2023 on shared 510(k) K210692
    • Ongoing Z-0277-2024 FDA Class II initiated 21 Sep 2023 on shared 510(k) K210692
    • Ongoing Z-0272-2024 FDA Class II initiated 21 Sep 2023
    • Ongoing Z-0278-2024 FDA Class II initiated 21 Sep 2023 on shared 510(k) K210692
    • Ongoing Z-0273-2024 FDA Class II initiated 21 Sep 2023 on shared 510(k) K210692

    Potential for units suspended on the ceiling to fail and fall.

  • 2 recalls, same reason

    • Ongoing Z-1326-2022 FDA Class II initiated 19 May 2021
    • Ongoing Z-1327-2022 FDA Class II initiated 19 May 2021

    Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

11 dated events

  1. Cleared FDA 510(k) K210692
  2. Recall initiated FDA recalls Z-1326-2022
  3. Recall initiated FDA recalls Z-1327-2022
  4. Recall initiated FDA recalls Z-0274-2024
  5. Recall initiated FDA recalls Z-0277-2024
  6. Recall initiated FDA recalls Z-0272-2024
  7. Recall initiated FDA recalls Z-0278-2024
  8. Recall initiated FDA recalls Z-0273-2024
  9. Registered EUDAMED 0884838BM440SS
  10. Recall initiated FDA recalls Z-0464-2026

1 earlier event are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
DigitalDiagnost 4 Flex / Value EUDAMED
DigitalDiagnost GUDID
Generic name
Stationary basic diagnostic x-ray system, digital
Device name
Fixed Rad-System
Model / Ref / Catalog
712032
Primary DI / UDI-DI
00884838074514
Basic UDI-DI
0884838BM440SS
FDA product code
MQB, KPR, LLZ
EMDN code
Z11039099 Various radiodiagnostic and interventional instruments – other
GMDN term
Stationary basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1680, 892.2050
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
DE-MF-000005362

Related devices

Category: Electromagnetic surgical navigation device tracking system

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Properties

  • Prescription use
  • Combination product
  • Serial number
Other properties (22, all answered No)