Recall Z-1140-2008 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
B & K Medical Systems, Inc.
B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887
| Date | Jun 10, 2008 (initiated Jan 24, 2008) |
| Status | Terminated |
| Reason | Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization. |
| Root cause | Process control |
| Action | B-K Medical issued letter notification on 1/23/08 to accounts via Fed Ex, advising them not to use the unit until a representative can inspect and exchange, if unit is found defective. Instructions are also provided to continue use of the device with a sterile cover until site visit. |
| Quantity | 7 |
| Distribution | USA Distribution: MA, MI, PA, TX, and OR. |
| FDA record | Open on fda.gov |