Device product
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Z-1138-2023
Product summary
- Event
- Event 91538
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 893 units
- Official record key
device-enforcement:Z-1138-2023
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: 04048675040552 (MP01579); 04048675040569 (MP01580); 04048675040538 (MP01581)
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.