CLASS II Device recall · Reported 29 Aug 2018 · FDA Enforcement Report
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) recalled
Philips Medical Systems Gmbh, DMC is recalling DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028, distributed nationwide in the US. The recall was initiated on 27 Jun 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2850-2018
- FDA event ID
- 80577
- Recalling firm
- Philips Medical Systems Gmbh, DMC, Hamburg
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2018
- FDA classified
- 17 Aug 2018
- Reported
- 29 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 27 Jun 2018 | Recall initiated by company | |
| 17 Aug 2018 | Classified by FDA | +51 days |
| 29 Aug 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
Where it was distributed
US Nationwide; International to 66 countries
Questions about this recall
Is DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 recalled?
Yes. Philips Medical Systems Gmbh, DMC recalled DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 on 27 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-2850-2018.
Why was it recalled?
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Which lots are affected?
Serial Numbers: SN17000283 SN15000078 SN15000115 SN17000326 SN15000114 SN17000171 SN17000058 SN17000190 SN15000016 SN15000316 SN17000027 SN14000047 SN17000024 SN15000015 SN17000342 SN14000108
Where was it sold?
US Nationwide; International to 66 countries
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Medical Systems Gmbh, DMC
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | CombiDiagnost R90 recalled by Philips Medical Systems Gmbh | Philips Medical Systems Gmbh, DMC | Device Malfunction | Nationwide |
| Device | CLASS II | CombiDiagnost PCF recalled by Philips Medical Systems Gmbh | Philips Medical Systems Gmbh, DMC | Device Malfunction | Nationwide |
| Device | CLASS II | CombiDiagnost GCF recalled by Philips Medical Systems Gmbh | Philips Medical Systems Gmbh, DMC | Device Malfunction | Nationwide |
| Device | CLASS II | Stationary Fluoroscopic X-ray System CombiDiagnost R90 recalled | Philips Medical Systems Gmbh, DMC | Other | Nationwide |
| Device | CLASS II | Philips DigitalDiagnost recalled by Philips Medical Systems Gmbh | Philips Medical Systems Gmbh, DMC | Device Malfunction | Nationwide |
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