Z-0243-2008

OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series...

Name: Z-0243-2008 OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series...
Creator: Mizuho Orthopedic Systems Inc
Published: 2007-02-28
License: https://open.fda.gov/license/

Mizuho Orthopedic Systems Inc / initiated 2007-02-28 / Terminated / root cause: software

FDA source

Mizuho Orthopedic Systems Inc began a recall of OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series 6800 and 6822 included) on 2007-02-28. The reason FDA records is "Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0243-2008
Status: Terminated
Initiated: 2007-02-28
Posted: 2007-12-13
Terminated: 2008-12-18
Recalling firm: Mizuho Orthopedic Systems Inc
Product: OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series 6800 and 6822 included)
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.
Root cause tag: software
FDA root cause: Software design
Action: The firm issued a Product Correction Notification letter by mail on 02/28/2007 and follow up with phone calls. The letter notified users that a required no-cost upgrade of the removal and replacement of a microprocessor that controls the logic for the floor locking mechanism will be conducted by the recalling firm.
Quantity in commerce: 117 units
Distribution: Worldwide: USA product was distributed to 16 wholesale dealers, 212 medical facilities, 14 distributors throughout the US in the following states: AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, MA, MD, ME, MI, MO, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, VA, WA, WI, WV and WY and to the following countries Taiwan, Australia, German, Japan, Canada, Saudi Arabia, and The UK.
Product codes and lots: Serial Numbers: 12-15, 17, 19, 21-57, 59-61, 64-67, 70, 71, 73-83, 85-93, 95, 97, 99-134 and 136-141

Product code LHN

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)