Recall Z-0924-2011 ยท JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Mizuho Orthopedic Systems Inc
Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA.
| Date | Jan 20, 2011 (initiated Mar 30, 2010) |
| Status | Terminated |
| Reason | 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 | 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 upgrad |
| Quantity | 17 units |
| Distribution | Worldwide Distribution -- USA & Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.