Device product
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
Z-1137-2023
Product summary
- Event
- Event 91538
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 16 units
- Official record key
device-enforcement:Z-1137-2023
Official wording
Reason: The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
Code information: All Lot numbers. UDI-DI: 04048675041146 (MP10576); 04048675041153 (MP01577); 04048675041160 (MP01578)
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.