OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series 6800 and 6822
FDA device recall Z-0243-2008 · posted 2007-12-13 · Terminated
Recall details
- Recalling firm
- Mizuho Orthopedic Systems Inc
- Reason for recall
- Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LHN
- Quantity affected
- 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, M
- Date initiated
- 2007-02-28
- Date posted
- 2007-12-13
- Date terminated
- 2008-12-18
- Location
- Union City, CA
Monitor recalls programmatically
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