Philips Medical Systems DMC GmbH FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection VAI · Jan 19, 2023
  • No warning letters matched by name
Inspections 3 0 OAI
Recalls 11 0 Class I (0%)
Warning letters 0 None on file
510(k) clearances 18 Latest Jun 13, 2024

Philips Medical Systems DMC GmbH has 11 FDA recalls, 3 inspections, 18 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Philips Medical Systems DMC GmbH" is on file.

What these totals cover: FDA records filed under the name "Philips Medical Systems DMC GmbH" and its spelling variant "Philips Medical Systems Dmc". Records filed under related names are not included; see Related names.

Latest recall
Z-0300-2027 · Oct 6, 2026 · filed under Philips Medical Systems Nederland
Latest recall under this name
Z-0466-2026 · Class II · Oct 1, 2025
Latest inspection
Jan 19, 2023 · VAI
Latest 510(k)
Jun 13, 2024

Newer recall under related name Philips Medical Systems Nederland: Oct 6, 2026, Z-0300-2027.

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls11Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances18Nov 15, 2026File dated Nov 9, 2026Current
Inspections3Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Philips Medical Systems DMC GmbH's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Philips Medical Systems DMC GmbH: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500060
202400000
202310000
202200000
202100050
202000000
201900000
201800000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Reviewing Philips Medical Systems DMC GmbH as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Philips Medical Systems DMC GmbH yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Recent recalls

11 recall records from May 19, 2021 to Oct 1, 2025.

NumberClassProductDate
Z-0466-2026Class IIRadiography 7300 C; Model Number: 712037;Oct 1, 2025
Z-0462-2026Class IICombiDiagnost R90; Model Number: 709031;Oct 1, 2025
Z-0464-2026Class IIDigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;Oct 1, 2025
Z-0463-2026Class IIPrecision CRF; Model Number: 706400;Oct 1, 2025
Z-0461-2026Class IIProxiDiagnost N90; Model Number: 706110;Oct 1, 2025
Z-0465-2026Class IIDigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2)…Oct 1, 2025
Z-1327-2022Class IIDigitalDiagnost 4 Flex / Value. radiography and fluoroscopy systemMay 19, 2021
Z-1325-2022Class IIProxiDiagnost N90. radiography and fluoroscopy systemMay 19, 2021
Z-1326-2022Class IIDigitalDiagnost 4 High Performance. radiography and fluoroscopy systemMay 19, 2021
Z-1328-2022Class IIDigitalDiagnost C90 High Performance. radiography and fluoroscopy systemMay 19, 2021
Z-1329-2022Class IIDigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy systemMay 19, 2021

Recent FDA inspections

3 inspections from Jun 14, 2013 to Jan 19, 2023.

DateSiteProductClassificationFEI
Jan 19, 2023Hamburg, GermanyDevicesVoluntary Action Indicated (VAI)3003768251
Jul 9, 2015Hamburg, GermanyDevicesNo Action Indicated (NAI)3003768251
Jun 14, 2013Hamburg, GermanyDevicesNo Action Indicated (NAI)3003768251
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3003768251Hamburg, Germany3Jan 19, 2023

Recent 510(k) clearances

18 510(k) clearances from Oct 7, 2013 to Jun 13, 2024.

K-NumberDeviceDate
K233662Radiography 7300 CJun 13, 2024
K233678Radiography 7000 MFeb 14, 2024
K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Jan 11, 2024
K232910CombiDiagnost R90Oct 19, 2023
K212186Philips Radiology Smart AssistantDec 13, 2021
K212837ProxiDiagnost N90Sep 21, 2021
K210692DigitalDiagnostApr 2, 2021
K203087CombiDiagnost R90Dec 3, 2020
K202564DigitalDiagnost C90Sep 30, 2020
K182973DigitalDiagnost C90Jan 11, 2019
K173433ProxiDiagnost N90Feb 5, 2018
K171461SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsJul 7, 2017
K170113pixium 4343RCEFeb 9, 2017
K163210Philips CombiDiagnost R90Jan 31, 2017
K153318Philips Eleva Workspot with SkyFlowDec 22, 2015
K141736PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOSTJul 25, 2014
K140771PHILIPS ELEVA WORKSPOTApr 25, 2014
K131483PHILIPS PIXIUM 4343RCOct 7, 2013

Philips Medical Systems DMC GmbH and the FDA: common questions

Has Philips Medical Systems DMC GmbH received an FDA warning letter?

No FDA warning letter addressed to the name "Philips Medical Systems DMC GmbH" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Philips Medical Systems DMC GmbH received an FDA Form 483?

FDA has not published a Form 483 for "Philips Medical Systems DMC GmbH" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Philips Medical Systems DMC GmbH?

The most recent FDA inspection on file ended Jan 19, 2023 at Hamburg, Germany and was classified VAI. FDA has 3 inspections of Philips Medical Systems DMC GmbH on file.

Has Philips Medical Systems DMC GmbH had an FDA recall?

Yes. Philips Medical Systems DMC GmbH has 11 FDA recalls on record. The most recent under this name started Oct 1, 2025. A newer recall, dated Oct 6, 2026, is filed under the related name Philips Medical Systems Nederland.

Need more than this page shows? Ask about Philips Medical Systems DMC GmbH in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.

Get a free API key

Prefer a PDF? Request a free supplier snapshot.

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.