Recall Z-1293-2021— Mizuho OSI
Class II · Ongoing
Class II FDA medical device recall by Mizuho OSI, initiated 2021-02-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- Mizuho OSI
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-02-08
- Firm location
- Union City, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.