Device product
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
Z-1354-2025
Product summary
- Event
- Event 96343
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 170 kits
- Official record key
device-enforcement:Z-1354-2025
Official wording
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Code information: UDI-DI 00191072212900 00191072218001 Lots 960241 71-050727 71-051234 71-051771 71-052322 71-052501 71-052705
Distribution pattern: US Nationwide distribution in the state of OH.
Derived failure modes
-
Unknown
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.