Recall Z-0792-2016 ยท GDC Table, Operating-Room, Electrical
Mizuho OSI
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.
| Date | Feb 9, 2016 (initiated Dec 14, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | All consignees were notified by telephone and a recall letter was mailed to each facility as a follow up. Customers were asked to remove tables from operation until they were inspected by OSI service personnel. |
| Quantity | 33 |
| Distribution | US, South Africa, Japan and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.