Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City,

FDA device recall Z-0924-2011 · posted 2011-01-20 · Terminated

Recall details

Recalling firm

Mizuho Orthopedic Systems Inc

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.

Action taken

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.*******

Root cause

Device Design

Status

Terminated

Product code

JEA

Quantity affected

17 units

Distribution

Worldwide Distribution -- USA & Germany.

Date initiated

2010-03-30

Date posted

2011-01-20

Date terminated

2011-05-17

Location

Union City, CA