Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating

FDA device recall Z-0792-2016 · posted 2016-02-09 · Terminated

Recall details

Recalling firm

Mizuho OSI

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.

Action taken

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

Status

Terminated

Product code

GDC

Quantity affected

33

Distribution

US, South Africa, Japan and United Arab Emirates.

Date initiated

2015-12-14

Date posted

2016-02-09

Date terminated

2016-02-10

Location

Union City, CA