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) 712022, 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-2859-2018
- 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) 712022
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: 488713/SN11000577 488714/SN11000572 444623/SN10000136 480503/SN11000473 480504/SN11000478 410040/SN08000021 422832/SN09000061 462407/SN10000363 448130/SN10000008 464981/SN10000471 455752/SN10000200 454061/SN10000216 426292/SN09000386 455546/SN10000143 420090/SN09000018 474817/SN11000080 474238/SN11000042 461799/SN10000347 455621/SN10000163 471148/SN11000122 471147/SN11000120 482904/SN11000375 482905/SN11000373 482903/SN11000379 440249/SN09000347 481021/SN11000446 487808/SN11000526 441778/SN09000452 432989/SN09000285 478307/SN12000004 476338/SN12000026 476034/SN12000027 422536/SN09000199 486638/SN11000494 466808/SN10000464 462593/SN10000439 471150/SN10000660 478233/SN11000233 473897/SN11000165 482501/SN11000527 453200/SN10000133 456093/SN10000204 461979/SN10000701 461976/SN10000704 443093/SN09000454 445110/SN09000461 16750755 477524/SN11000434 475932/SN11000341 475866/SN11000350 451542/SN10000098 442534/SN09000423 443443/SN09000420 484558/SN11000525 479928/SN11000287 466029/SN10000420 472613/SN11000162 480061/SN11000474 453085/SN10000125 467927/SN10000713 450779/SN10000062 480881/SN11000274 476835/SN11000179 442005/SN10000298 444627/SN10000142 442310/SN10000149 478181/SN11000455 481142/SN11000318 467348/SN11000207 441637/SN09000354 441638/SN09000356 464863/SN10000533 464880/SN10000714 421977/SN09000115 449365/SN10000110 464755/SN10000391 430355/SN09000214 451543/SN10000100 ***Added 5/6/21*** SN15000449
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 |
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