Recall Z-0091-2021— Mizuho OSI
Class II · Terminated
Class II FDA medical device recall by Mizuho OSI, initiated 2019-10-14, terminated 2023-09-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.. Reason: Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead to a failure of the locking mechanism.
- Recalling firm
- Mizuho OSI
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-14
- Terminated
- 2023-09-27
- Firm location
- Union City, CA, United States
Product description
Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.
Reason for recall
Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead to a failure of the locking mechanism
Data sourced from openFDA. This site is unofficial and independent of the FDA.