Skip to content
Recall Observatory FDA recall evidence

Device product

NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)

Z-1138-2023

January 23, 2023

Class I

Product summary

Firm
Draeger Medical, Inc.
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

    reason.no_named_rule · v1.0.0

    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.