FDA Medical Device Recalls (openFDA)
Philips Medical Systems Gmbh, DMC: DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
- Recall number
- Z-2845-2018
- Recalling firm
- Philips Medical Systems Gmbh, DMC
- Product
- DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
- 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: SN13000495 SN14000058 SN13000463 SN14000051 SN14000214 SN14000047 SN14000077 SN13000484 SN14000082 SN14000163 SN14000133 SN14000134 SN14000134 SN14000023 SN14000041
- 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