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Philips Medical Systems DMC GmbH FDA Inspection Record

FEI 3003768251 · Inspections, Form 483s, warning letters and import refusals

Philips Medical Systems DMC GmbH is an FDA-registered facility (FEI 3003768251) located in HAMBURG, DE. RegDataLab tracks 3 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Jan 19, 2023: Voluntary Action Indicated (VAI)
Inspections on record
3 (1 VAI, 2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
7, latest Oct 1, 2025
Import refusals
2

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Jan 19, 2023Voluntary Action Indicated (VAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Report of violation of the Act (see 803.52(e)(9)) (21 CFR 806.10(a)(2))
Jul 9, 2015No Action Indicated (NAI)No citations listed
Jun 14, 2013No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Oct 1, 2025Class IIZ-0461-2026ProxiDiagnost N90; Model Number: 706110; and 5 more products
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to…
May 19, 2021Class IIZ-1325-2022ProxiDiagnost N90. radiography and fluoroscopy system and 4 more products
Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an…
Jul 22, 2020Class IIZ-2357-2021CombiDiagnost R90 Software Version R1.0 and R1.1
Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter…
Dec 19, 2019Class IIZ-1328-2020CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system… and 1 more product
When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the…
Nov 7, 2018Class IIZ-0612-2019Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary…
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Sep 19, 2018Class IIZ-0239-2019Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models…
Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD…
Jun 27, 2018Class IIZ-2841-2018DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 and 27 more products
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator…

FDA record score

14 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

8 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-0461-2026, this FEI as the recalling firmOct 1, 20254 x 14
Inspection classified VAIJan 19, 20236 x 0.63.6
Class II recall Z-1325-2022, this FEI as the recalling firmMay 19, 20214 x 0.251
Class II recall Z-2357-2021, this FEI as the recalling firmJul 22, 20204 x 0.251
Class II recall Z-1328-2020, this FEI as the recalling firmDec 19, 20194 x 0.251
Class II recall Z-0612-2019, this FEI as the recalling firmNov 7, 20184 x 0.251
Class II recall Z-0239-2019, this FEI as the recalling firmSep 19, 20184 x 0.251
Class II recall Z-2841-2018, this FEI as the recalling firmJun 27, 20184 x 0.251

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Philips Medical Systems DMC GmbH
Location
HAMBURG (DE)
Source
device

Import refusals

FDA data resources

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