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Terminated

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.

FDA Recall Z-0792-2016 · Posted 2016-02-09

Recalling FirmMizuho OSI
Recall StatusTerminated
Product CodeGDC
Date Initiated2015-12-14
Date Terminated2016-02-10
Product Quantity33

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.

Firm 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.

Root Cause

Employee error

Distribution Pattern

US, South Africa, Japan and United Arab Emirates.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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