CLASS II Device recall · Reported 29 Aug 2018 · FDA Enforcement Report
DigitalDiagnost 4 High Performance recalled
Philips Medical Systems Gmbh, DMC is recalling DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027, 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-2851-2018
- 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 High Performance (Stitching Patient Support) 712027
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: SN17000294 SN17000295 SN17000114 SN17000185 SN17000362 SN17000263 SN17000264 SN17000399 SN15000017 SN17000235 SN18000001 SN17000414 SN17000376 SN16000352 SN17000311 SN17000070 SN14000079 SN14000080 SN17000044 SN17000346 SN14000052 SN17000045 SN17000351 SN17000038 SN17000262 SN17000126 SN15000122 SN17000100 SN17000422 SN17000359 SN16000390 SN15000048 SN17000084 SN16000386 SN17000106 SN17000288 SN17000278 SN17000335 SN16000394 SN16000387 SN17000151 SN17000352 SN17000329 SN17000349 SN17000303 SN17000334 SN17000216 SN17000305 SN17000398 SN15000328 SN17000289 SN17000411 SN17000436 SN17000090 SN15000006 SN17000179 SN17000034 SN17000231 SN16000355 SN17000166 SN17000127 SN16000421 SN16000398 SN14000105 SN16000430 SN16000418 SN17000150 SN17000092 SN15000054 SN15000097 SN15000110 SN17000373 SN15000132 SN14000040 SN14000045 SN15000098 SN16000435 SN15000142 SN15000151 SN17000141 SN15000410 SN15000417 SN16000402
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 |