Device product
DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
Z-2854-2018
Product summary
- Event
- Event 80577
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2854-2018
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: SN16000197 SN15000288 SN16000234 SN16000008 SN15000304 SN15000283 SN15000174 SN15000225 SN16000124 SN16000023 550162 SN15000350 SN16000092 SN15000379 SN16000283 SN16000104 SN15000173
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.