Device product
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
Z-2841-2018
Product summary
- Event
- Event 80577
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-2841-2018
Official wording
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.
Code information: Serial Numbers: 496224/SN12000042, 431530/SN09000159
Distribution pattern: US Nationwide; International to 66 countries
Derived failure modes
-
Unknown
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.