Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.
FDA device recall z-2640-2010 · posted 2010-10-01 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LFL
- Quantity affected
- 1161
- Distribution
- Wordwide
- Date initiated
- 2010-07-15
- Date posted
- 2010-10-01
- Date terminated
- 2011-10-19
- Location
- Kalamazoo, MI
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