Reported Feb 17, 2016 · Terminated
Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating…
Mizuho OSI
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mizuho OSI · 30031 Ahern Ave · Union City, CA · 94587-1234
Is this the product you have?
- Mizuho OSI Trios, Table Base
- Voltage100-240V ~ 50/60
- Hz Amps
50-5.0A
- Model 7803 and 7803AP OrthopaedicOperating 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
- Lot codes and dates
Model numbers 78037803AP. Serial numbers 228-261
- Amount recalled
- 33
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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