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Recall Observatory FDA recall evidence

Device 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.

Z-0792-2016

December 14, 2015

Class II

Product summary

Firm
Mizuho OSI
Event
Event 72937
Status
Terminated
Classification
Class II
Quantity
33
Official record key
device-enforcement:Z-0792-2016

Official wording

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.

Code information: Model numbers 7803, 7803AP. Serial numbers 228-261.

Distribution pattern: US, South Africa, Japan and United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.