Recall Z-0243-2008 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Mizuho Orthopedic Systems Inc
OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series 6800 and 6822 included)
| Date | Dec 13, 2007 (initiated Feb 28, 2007) |
| Status | Terminated |
| Reason | Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly. |
| 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 | 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 count |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.