Device product
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
Z-2867-2018
Product summary
- Event
- Event 80577
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2867-2018
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: 470350/SN10000103 482735/SN11000053 475222/SN11000013 486215/SN11000104 484559/SN11000063 77124552 499144/SN12000035 502428/SN12000048 505693/SN12000054
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.