FDA Medical Device Recalls (openFDA)
Philips Medical Systems Gmbh, DMC: DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
- Recall number
- Z-2858-2018
- Recalling firm
- Philips Medical Systems Gmbh, DMC
- Product
- DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
- Status
- Terminated
- Initiated
- 2018-06-27
- Posted
- 2018-08-17
- Terminated
- 2024-04-30
- Reason
- 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.
- Root cause
- Device Design
- Action
- On June 27, 2018, Philips Medical Systems issued URGENT FIELD SAFETY NOTICES, Medical Device Recall letters to customers. Customers were encouraged to always check the right position of the hook and ensure that the hook is locked according tot he IFU. Press hook down until it is locked. Make sure that the hook is in position. A Philips Service Engineer will contact impacted customers as soon as the Field Action Kit is ready to be implemented. Should you need to communicate with Philips in regards to this program, please reference FCO-71200185. If you need further information or support concerning this issue, please contact your local Philips representative.
- Quantity
- not on file
- Distribution
- US Nationwide; International to 66 countries
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K090625"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 3003768251
- Firm city
- Hamburg
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28