Device product
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
Z-2850-2018
Product summary
- Event
- Event 80577
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2850-2018
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: SN17000283 SN15000078 SN15000115 SN17000326 SN15000114 SN17000171 SN17000058 SN17000190 SN15000016 SN15000316 SN17000027 SN14000047 SN17000024 SN15000015 SN17000342 SN14000108
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.