FDA Medical Device Recalls (openFDA)
B & K Medical Systems, Inc.: Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667
- Recall number
- Z-0856-06
- Recalling firm
- B & K Medical Systems, Inc.
- Product
- Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667
- Status
- Terminated
- Initiated
- 2006-03-16
- Posted
- 2006-05-09
- Terminated
- 2006-10-12
- 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
- Lot, serial or model codes
- Serial Numbers: 1855380, 1855547, 1855548, 1856835, 1856837, 1857171, 1857173, 1857180, 1857427, 1857435, 1857515, 1857748, 1858482, 1858841, 1859751, 1859902, 1860250, 1860262, 1860487, 1860661, 1860858, 1861488, 1861580, 1861581, 1861823, 1861849, 1863084, 1863082
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 1000305740
- Firm city
- Wilmington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28