FDA Medical Device Recalls (openFDA)
Mizuho Orthopedic Systems Inc: Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA.
- Recall number
- Z-0924-2011
- Recalling firm
- Mizuho Orthopedic Systems Inc
- Product
- Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA.
- Status
- Terminated
- Initiated
- 2010-03-30
- Posted
- 2011-01-20
- Terminated
- 2011-05-17
- Reason
- 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.
- Root cause
- 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
- 17 units
- Distribution
- Worldwide Distribution -- USA & Germany.
- Lot, serial or model codes
- all units.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JEA
- Firm FEI
- 2921578
- Firm city
- Union City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28