Mizuho OSI Trios — Class II medical device recall Z-0792-2016
Terminated recall by Mizuho OSI, reported 2016-02-17. Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over tim
| Recall number | Z-0792-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mizuho OSI, Union City, CA, United States |
| Recall initiated | 2015-12-14 |
| Classified | 2016-02-09 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2016-02-10 |
| Countries outside the US | AE, JP, ZA |
| Quantity | 33 |
| Serial numbers | 228-261 |
| Model numbers | 7803, 7803AP |
Product
Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.
Reason for recall
Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over time, the parts could go out of alignment, making clutch engagement or disengagement difficult. If the clutch cannot disengage, the user would be unable to rotate the patient from supine to prone.
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-0792-2016. 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.