Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667
FDA Recall Z-0856-06 · Posted 2006-05-09
Recalling FirmB & K Medical Systems, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2006-03-16
Date Terminated2006-10-12
Product Quantity28 units
Reason for Recall
Due to a problem with calibration, the device can produce up to 50% elevated acoustic output and up to 2 degrees higher surface temperature
Firm 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 .
Root Cause
Other
Distribution Pattern
CA,CT, FL, MD, ME, MN, MS, NY, OH, RI, SD, TX, VA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.