CLASS II Device recall · Reported 29 Aug 2018 · FDA Enforcement Report
DigitalDiagnost Release 3 (Stitching Patient Support) recalled
Philips Medical Systems Gmbh, DMC is recalling DigitalDiagnost Release 3 (Stitching Patient Support) 712025, 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-2861-2018
- 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 Release 3 (Stitching Patient Support) 712025
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: SN13000132 514201/SN12000334 SN13000145 485094/SN11000028 485093/SN11000029 SN13000150 498131/SN12000072 515567/SN12000365 SN13000186 SN13000227 SN13000280 514978/SN12000374 514917/SN12000338 520248/SN13000057 512305/SN12000296 499378/SN12000065 515647/SN12000361 SN13000162 SN13000322 SN13000388 SN13000440 518940/SN13000015 498389/SN12000046 SN13000419 SN13000183 497871/SN12000116 497872/SN12000123 SN13000170 493886/SN12000067 SN13000247 521377/SN13000113 512184/SN12000267 514540/SN12000384 514291/SN12000322 506687/SN12000184 506685/SN12000185 515888/SN12000342 515889/SN12000357 519026/SN13000028 514210/SN12000313 505513/SN12000302 519509/SN13000056 492928 515713/SN13000093 SN13000426 513549/SN12000332 504226/SN12000212 513792/SN12000295 SN13000260 514303/SN12000395 494356/SN12000005 515262/SN12000324 SN13000311 SN13000111 496399/SN12000118 496394/SN12000045 497058/SN12000030 518706/SN13000045 506258/SN12000152 519609/SN13000060 512167/SN13000097 SN13000342 504404/SN12000223 519329/SN13000044 SN13000265 192929/SN11000055 SN13000447 SN13000366 SN13000456 504665/SN12000213 521255/SN13000104 491790/SN11000073 495027/SN12000034 517758/SN12000389 SN13000341 SN13000314 504769/SN12000214 488603/SN11000063 489349/SN11000067 514290/SN13000013 512235/SN12000289 SN13000176 515464/SN12000327 491708/SN12000001 497889/SN12000106 492192/SN12000028 SN13000336 SN13000143 499759/SN12000080 503540/SN12000197
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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