Z-0856-06

Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667

Name: Z-0856-06 Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667
Creator: B & K Medical Systems, Inc.
Published: 2006-03-16
License: https://open.fda.gov/license/

B & K Medical Systems, Inc. / initiated 2006-03-16 / Terminated / root cause: manufacturing process

FDA source

B & K Medical Systems, Inc. began a recall of Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667 on 2006-03-16. The reason FDA records is "Due to a problem with calibration, the device can produce up to 50% elevated acoustic output and up to 2 degrees higher surface temperature". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0856-06
Status: Terminated
Initiated: 2006-03-16
Posted: 2006-05-09
Terminated: 2006-10-12
Recalling firm: B & K Medical Systems, Inc.
Product: Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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
Root cause tag: manufacturing process
FDA 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 in commerce: 28 units
Distribution: CA,CT, FL, MD, ME, MN, MS, NY, OH, RI, SD, TX, VA
Product codes and lots: 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

Product code IYN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)