FDA Device recall Z-0091-2021
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 M…
- FDA Device
- Class II
- terminated
- Published 2020-10-21
On 2020-10-21 the FDA classified a Class II recall of 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 M… by Mizuho Osi, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0091-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-14 |
| Published | 2020-10-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Mizuho Osi |
| Distribution | US |
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
Identifiers
| code_info | Model Number: 7887-050 UDI/GTIN 00842230104992 Affected Serial Numbers: 201 through 452 Model 7887-050R UDI/GTIN…Model Number: 7887-050 UDI/GTIN 00842230104992 Affected Serial Numbers: 201 through 452 Model 7887-050R UDI/GTIN 00824230108440 Affected Serial Numbers: 234, 235, 248, 255, 341, and 448 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0091-2021%22
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