Reported Oct 21, 2020 · Terminated
Levo Arm Label
Mizuho OSI
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mizuho OSI · 30031 Ahern Ave · Union City, CA · 94587-1234
Is this the product you have?
Levo Arm Label
3 of 3 products
| Model / number | Product as published |
|---|---|
7887-050 | MIZUHO OSI |
| — | Refurbished Levo Arm Label: LEVO ARM |
7887-050R | MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery. |
- Lot codes and dates
- Model Number7887-050 UDI/GTIN 00842230104992
- Affected Serial Numbers201 through 452 Model 7887-050R UDI/GTIN 00824230108440
- Affected Serial Numbers
234235248255341and 448
- Amount recalled
- 174 Arms
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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