Recall Z-0792-2016— Mizuho OSI
Class II · Terminated
Class II FDA medical device recall by Mizuho OSI, initiated 2015-12-14, terminated 2016-02-10. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Mizuho OSI
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-14
- Terminated
- 2016-02-10
- Firm location
- Union City, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.