Mizuho OSI 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Mizuho OSI
Lot Codes / Batch Numbers
235, 248, 255, 341, and 448
Products Sold
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
Mizuho OSI is recalling Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
On 10/14/2019, the firm sent an "URGENT: Medical Device Recall" notification to customers via courier (e.g., UPS or FedEx) and an email to distributors informing them that they have become aware of the potential for fluid ingress rendering the internal electronics inoperable and leading to a failure of the Arm's locking mechanism. The Recalling Firm is instructing customers that they can continue to use the Arm until a replacement Arm is provided, but if either of the following scenarios apply to the devices, to please cease uses immediately and contact the Recalling Firm's Service Department. The two scenarios are: -The customer believes the Arm has been exposed to excessive fluids at any point while in use; -The customer notices any slipping of the Arm while properly installed for its intended use. Customers are asked to refer to the Owner's Manual for specific instructions on how to properly clean all modules of the Head Positioning System, including the Arm. Instructions are found in Section 13 of the manual. In addition, the cleaning instructions are included within the Customer Notification Letter. The Recalling Firm is proactively replacing Arms. Customer should follow the instruction regarding the Exchange Program: -Recalling Firm will provide a replacement Arm at no charge. The timing of the replacement will be based upon product availability and is expected to be completed within 16 weeks. -The Recalling Firm's Sales or Service members will assist customers with the packaging and return of the existing Arm(s) upon the receipt of the upgraded model. Customers are also asked to respond to the Customer Notification Letter by: 1. Confirm receipt and understanding of the notice by signing and returning the response portion of the Notification letter to the Recalling Firm's Regulatory Department at: FAX Number +1-510-429-9945 or email notice@mizuhosi.com 2. Any questions about the exchange plan, call the Recalling Firm's Service Department a
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026