ROSA Surgical Device 2.5.8
Hazard
Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
What You Should Do
Remedy
Field Service Technicians were dispatched to correct units by upgrading the system to ROSA 2.5.7. A further update of ROSA 2.5.8.4. A Field Safety Notice dated 07/10/2013 notifying consignees of a risk in the ROSA system recognized in internal testing. It was suggested that consignees not utilize the neuro-endoscopy module until further notice. The recall notice should have been shared with the appropriate parties and the signed acknowledgement form returned to the recalling firm.
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Products
ROSA Surgical Device 2.5.8
- Brand
- Zimmer Biomet, Inc.
- UPC
- Serial No. RO10011, RO10014, RO13023 and RO13027
Units Affected
22 units (4 US and 18 OUS)