Z-0792-2016 Class II Terminated
FDA device recall Z-0792-2016 was initiated by Mizuho OSI on Dec 14, 2015 and is designated Class II. 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… The recall status is terminated (terminated Feb 10, 2016). Affected quantity: 33.
Recall details
- Product Type
- Devices
- Report Date
- Feb 17, 2016
- Initiation Date
- Dec 14, 2015
- Termination Date
- Feb 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0792-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026