FDA Medical Device Recalls (openFDA)
Philips Medical Systems Gmbh, DMC: DigitalDiagnost Single Detector (Stitching Patient Support) 712020
- Recall number
- Z-2863-2018
- Recalling firm
- Philips Medical Systems Gmbh, DMC
- Product
- DigitalDiagnost Single Detector (Stitching Patient Support) 712020
- 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: 399921/SN08000023 410038/SN08000091 402577/SN09000137 479651/SN11000391 443237/SN09000411 496881/SN12000104 489345/SN11000590 459498/SN10000231 483525/SN11000377 468302/SN10000537 485692/SN11000443 422533/SN09000072 450553/SN10000089 414087/SN08000100 472611/SN11000056 443235/SN09000450 481036/SN11000471 471070/SN10000695 471047/SN10000700 455221/SN10000251 460072/SN10000336 478109/SN11000327 475856/SN11000315 415754/SN08000063 443660/SN10000010 440700/SN10000030 440260/SN09000350 447603/SN09000468 448647/SN10000111 467487/SN11000085 467484/SN10000602 477526/SN11000311 490997/SN12000106 451267/SN10000104 445433/SN09000434 488711/SN11000615 470906/SN11000142 485620/SN12000002 448671/SN10000076 480052/SN11000286 480053/SN11000288 439920/SN09000329 412942/SN08000036 418438/SN08000110 431111/SN09000237
- 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