Recall z-2640-2010 ยท LFL Instrument, Ultrasonic Surgical
Stryker Instruments Div. of Stryker Corporation
Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.
| Date | Oct 1, 2010 (initiated Jul 15, 2010) |
| Status | Terminated |
| Reason | Stryker Instruments acquired the Sonopet Ultrasonic Surgical System from Mutoh co. Ltd on 3/29/2010. Stryker determined that the Sonopet consode did not meet the IEC-60601-1 standard. Stryker decided to recall the Sonopet consode. |
| Root cause | Device Design |
| Action | The firm to send URGENT MEDICAL DEVICE RECALL NOTIFICATIONS to customers dated 7/15/2010. The customers were instructed to continue to use the device. Stryker technicians were dispatched to replace a board with a new board. |
| Quantity | 1161 |
| Distribution | Wordwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.