Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667
FDA device recall Z-0856-06 · posted 2006-05-09 · Terminated
Recall details
- Recalling firm
- B & K Medical Systems, Inc.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 28 units
- Distribution
- CA,CT, FL, MD, ME, MN, MS, NY, OH, RI, SD, TX, VA
- Date initiated
- 2006-03-16
- Date posted
- 2006-05-09
- Date terminated
- 2006-10-12
- Location
- Wilmington, MA
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