Recall Z-1293-2021 ยท GDC Table, Operating-Room, Electrical
Mizuho OSI
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.
| Date | Feb 8, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 2/3/2021 Mizuho sent a "Recall Notice for Control Unit" notification letter to affected consignees via Email. In addition to informing consignees about the recall the notification asked consignees to take the following actions: 1. Identify if you have the affected product, 2. Mizuho will replace control units. As soon as we are ready for your institutions, Mizuho will supply the replacements. Please use the auxiliary switch on the operating table until the replacements arrive. |
| Quantity | 26 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of CA, and the countries of Costa Rica, Chile, Bolivia, Peru. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.