Mizuho CE IPX4 — Class II medical device recall Z-1293-2021
Ongoing recall by Mizuho OSI, reported 2021-03-31, distributed nationwide. There is a potential that hand control units may cause the tabletop to slide in the opposite direction from th
| Recall number | Z-1293-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mizuho OSI, Union City, CA, United States |
| Recall initiated | 2021-02-08 |
| Classified | 2021-03-23 |
| Reported by FDA | 2021-03-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | BO, CL, CR, PE |
| Quantity | 26 units |
| Model numbers | 18-140-20 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1293-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.