Z-0924-2011

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

Name: Z-0924-2011 Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI...
Creator: Mizuho Orthopedic Systems Inc
Published: 2010-03-30
License: https://open.fda.gov/license/

Mizuho Orthopedic Systems Inc / initiated 2010-03-30 / Terminated / root cause: design

FDA source

Mizuho Orthopedic Systems Inc began a recall of Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA on 2010-03-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0924-2011
Status: Terminated
Initiated: 2010-03-30
Posted: 2011-01-20
Terminated: 2011-05-17
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.
Product code: JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
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.
Root cause tag: design
FDA 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 in commerce: 17 units
Distribution: Worldwide Distribution -- USA & Germany.
Product codes and lots: all units.

Product code JEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)