Mizuho OSI Recalls Levo Arms Due to Fluid Ingress Risk
Mizuho OSI is recalling 174 Levo Arms used in spinal surgery tables due to a potential fluid ingress issue that could cause the locking mechanism to fail.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential mechanical failure (locking mechanism) that poses a risk of harm to patients during surgery, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Mizuho OSI is recalling 174 Levo Arms (Model 7887-050 and 7887-050R) used with Mizuho OSI spinal surgery tables. These devices are used to provide patient head support and positioning during spinal surgery procedures.
The recall is being issued 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. The affected units were distributed worldwide, including nationwide in the United States and in several international countries such as Australia, Canada, and the United Kingdom.
Healthcare facilities and users should stop using the affected Levo Arms and contact Mizuho OSI for further instructions on how to proceed with the recall.
The recalled product
- 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.
- Manufacturer
- Mizuho OSI
- Affected units
- 174
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 235
- 248
- 255
- 341
- and 448
Distribution
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