Device product
DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052
Z-2857-2018
Product summary
- Event
- Event 80577
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2857-2018
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: 422102/SN0902020 435210/SN0902204 460471/SN1002019 433651/SN0902114 427610/SN0902108 470160/SN1102003 447013/SN1002008 445778/SN1002006 420208/SN0902019
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.