Recall Z-0856-06 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
B & K Medical Systems, Inc.
Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667
| Date | May 9, 2006 (initiated Mar 16, 2006) |
| Status | Terminated |
| Reason | Due to a problem with calibration, the device can produce up to 50% elevated acoustic output and up to 2 degrees higher surface temperature |
| Root cause | Other |
| Action | BK Medical notified customers by letter on 4/10/06 via FedEx advising user of the problem and scheduling the software correction by a Service representative visit . |
| Quantity | 28 units |
| Distribution | CA,CT, FL, MD, ME, MN, MS, NY, OH, RI, SD, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.