Device product
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
Z-2844-2018
Product summary
- Event
- Event 80577
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2844-2018
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: 510694/SN12000240 510890/SN12000259 511451/SN13000066 510334/SN12000218 511346/SN13000008 511214/SN12000353 12000161 510089/SN12000293
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.