Recall Z-0091-2021 ยท JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
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.
| Date | Oct 14, 2019 |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.