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U.S. Department of Health and Human Services

Class 2 Device Recall Levo Arm

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  Class 2 Device Recall Levo Arm see related information
Date Initiated by Firm October 14, 2019
Create Date October 09, 2020
Recall Status1 Terminated 3 on September 27, 2023
Recall Number Z-0091-2021
Recall Event ID 86482
Product Classification Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
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.
Code Information 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 
Recalling Firm/
Manufacturer		 Mizuho OSI
30031 Ahern Ave
Union City CA 94587-1234
For Additional Information Contact Anne LeBlanc
800-777-4674
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Device Design
Action 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
Quantity in Commerce 174 Arms
Distribution Worldwide distribution - U.S. Nationwide distribution including in states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, SC, TN, TX, VA, WI, and WV. The countries of Australia, Belgium, Canada, Columbia, Germany, Israel, South Korea, New Zealand, Poland, United Kingdom, and South Africa.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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