Union City, CA, United States
Mizuho OSI recalls
3 recalls recorded since 2018, most recently on 29 July 2021. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 29 July 2021
- Reason
- One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
- Distribution
- U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1573-2022
- HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Ongoing Class II Medical devices
- Recall started
- 8 February 2021
- Reason
- There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This could result in a delay in procedure.
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of CA, and the countries of Costa Rica, Chile, Bolivia, Peru.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1293-2021
- Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.
Terminated Class II Medical devices
- Recall started
- 14 October 2019
- Terminated
- 27 September 2023
- 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
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0091-2021
- 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 positioni
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.