Z-0792-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2016
- Initiation Date
- December 14, 2015
- Termination Date
- February 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33
Product Description
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.
Distribution Pattern
US, South Africa, Japan and United Arab Emirates.
Code Information
Model numbers 7803, 7803AP. Serial numbers 228-261.