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U.S. Department of Health and Human Services

Class 2 Device Recall Mizuho OSI Trios, Table Base

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  Class 2 Device Recall Mizuho OSI Trios, Table Base see related information
Date Initiated by Firm December 14, 2015
Date Posted February 09, 2016
Recall Status1 Terminated 3 on February 10, 2016
Recall Number Z-0792-2016
Recall Event ID 72937
Product Classification Table, operating-room, electrical - Product Code GDC
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.
Code Information Model numbers 7803, 7803AP.  Serial numbers 228-261.
Recalling Firm/
Manufacturer		 Mizuho OSI
30031 Ahern Ave
Union City CA 94587-1234
For Additional Information Contact Bill Bregar
800-777-4674 Ext. 166
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 33
Distribution US, South Africa, Japan and United Arab Emirates.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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