Recall Z-0243-2008
Mizuho Orthopedic Systems Inc · initiated February 28, 2007
Product
OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series 6800 and 6822 included)
Codes / 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
Reason for recall
Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.
FDA-determined cause: Software design
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.
Details
- Recall number
- Z-0243-2008
- Initiated
- February 28, 2007
- Posted by FDA
- December 13, 2007
- Terminated
- December 18, 2008
- Product code
- LHN – System, Radiation Therapy, Charged-Particle, Medical
- Quantity
- 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.
- Recalling firm
- Mizuho Orthopedic Systems Inc, Union City, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0241-2008 | OSI, Allegro 6800 Imaging Table (Operating), single pedestal AC or battery operated…Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly. | 02/28/2007Terminated |
| Z-0242-2008 | OSI ProFx Operating Room Table 6850 , Pelvic Reconstruction Orthopedic Surgery Table--…Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly. | 02/28/2007Terminated |