CLASS II Device recall · Reported 29 Aug 2018 · FDA Enforcement Report
DigitalDiagnost, Dual-Detector (Stitching Patient Support) recalled
Philips Medical Systems Gmbh, DMC is recalling DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052, 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-2865-2018
- 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, Dual-Detector (Stitching Patient Support) 712052
Where it was distributed
US Nationwide; International to 66 countries
Questions about this recall
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: 363679 404164/SN0802462 378830/SN0802004 341693 358494 359442 396571/SN0802311 359449 346075 382021/SN0802313 374374 404298/SN0802474 402570/SN0802420 373501 373500 382272/SN0802113 368428 382012/SN0702520 376667 356957 392502/SN0802179 407423/SN0802638 359767 368619 358641 357697 381998/SN0702488 413829/SN0802631 358320 400364/SN0802522 404166/SN0802441 356981 390272/SN0802364 390273/SN0802366 412482/SN0802683 348997 396576/SN0802233 372848 373508 383084/SN0802127
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
27 other products · FDA event 80577This product is part of a recall event; the main page for the event is BuckyDiagnost Ceiling System (Stitching Patient Support) recalled.
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 |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |