Mizuho OSI recalls Levo Arm Label models 7887-050 and 7887-050R due to potential fluid ingress causing electrical failure and locking mechanism issues during spinal surgery. Affected units have serial numbers listed in the recall notice.
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
Mizuho OSI is recalling Levo Arm Labels used in spinal surgery tables because fluid could enter the device and cause electrical problems, potentially failing the locking mechanism. This could lead to patient positioning issues during surgery if not fixed.
Fluid can enter the Levo Arm Label's electrical system, causing it to malfunction. This may lead to the locking mechanism failing during spinal surgery, potentially affecting patient positioning and safety.
Spinal surgery patients and medical staff using Mizuho OSI Levo Arm Labels with serial numbers 201-452 (model 7887-050) or 234, 235, 248, 255, 341, 448 (model 7887-050R). Medical facilities using these specific units are most at risk.
Check if your Levo Arm Label has serial numbers 201-452 for model 7887-050 or 234, 235, 248, 255, 341, 448 for model 7887-050R. These units were sold with Mizuho OSI spinal surgery tables.
Identify if your Levo Arm Label has serial numbers 201-452 (model 7887-050) or 234, 235, 248, 255, 341, 448 (model 7887-050R).
Fluid can enter the device's electrical system, causing potential failure of the locking mechanism during spinal surgery.
Check the serial numbers: model 7887-050 units with serial numbers 201-452 or model 7887-050R units with serial numbers 234, 235, 248, 255, 341, 448.
The recall does not require immediate stop use; however, affected units should be checked and addressed as per the recall instructions.
We’ve drafted a message you can send Mizuho OSI to request your refund or repair — edit it as you like.
Subject: Recall Z-0091-2021 — Mizuho OSI Mizuho OSI Hello, I own a Mizuho OSI that is covered by recall Z-0091-2021 from Mizuho OSI. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
