FDA recall Z-0091-2021

Mizuho OSI · Class II · device

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.

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.

Key facts

Status
Terminated
Initiation date
2019-10-14
Report date
2020-10-21
Termination date
2023-09-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Union City, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0091-2021