Mizuho OSI recalls Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Pro

Recalled October 21, 2020 · FDA recall Z-0091-2021 · Mizuho OSI

Hazard

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 Class II

Units

174 Arms

Sold at

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.

Description

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

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(s)

Mizuho OSI

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →