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U.S. Department of Health and Human Services

Class 2 Device Recall ProFx 6850

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  Class 2 Device Recall ProFx 6850 see related information
Date Initiated by Firm March 30, 2010
Date Posted January 20, 2011
Recall Status1 Terminated 3 on May 17, 2011
Recall Number Z-0924-2011
Recall Event ID 56859
Product Classification Ac-Powered Surgical Table with Orthopedic Accessories - Product Code JEA
Product Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA.
Code Information all units.
Recalling Firm/
Manufacturer		 Mizuho Orthopedic Systems Inc
30031 Ahern Ave
Union City CA 94587
For Additional Information Contact
800-777-4674
Manufacturer Reason
for Recall		 Device component spar gear box locks up and may result in failure of push pull tube, which may result in release of breaking and impact.
FDA Determined
Cause 2		 Device Design
Action All customers will be contacted to arrange for removal and shipping arrangements. Verification will be done by the Repair and Verification instructions for the leg spars, via registered letters. *******UPDATED INFO---The firm sent another notification letter---dated 12/22/10---which states in part: "****The upgrade involves the correction of your 6850 PROfx¿ spars (6850-2100) at your facility by a Qualified Technician. The spars shall be upgraded to remove the 6850-2123, Drive Bracket, Spar Push Rod and replace it with the 6850-2170, Drive Bracket, Spar Push Rod. Upon completion of the upgrade, the 6850-2123, Drive Bracket, Spar Push rod shall be returned to Mizuho OSI for processing.*******
Quantity in Commerce 17 units
Distribution Worldwide Distribution -- USA & Germany.
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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