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.
Check against the official notice below — it lists the full affected range.
Mizuho OSI has recalled 174 Levo Arms used with spinal surgery tables due to the potential for fluid to enter the device, which could damage the electrical system and cause the locking mechanism to fail. The recalled devices include both new units (model 7887-050 with serial numbers 201-452) and refurbished units (model 7887-050R with specific serial numbers 234, 235, 248, 255, 341, and 448). The affected arms were distributed worldwide, including across numerous U.S. states and countries including Canada, Australia, Germany, the United Kingdom, and South Korea.
The recall notice does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 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. Quantity: 174 Arms Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.