Z-1140-2008

B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc...

Name: Z-1140-2008 B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc...
Creator: B & K Medical Systems, Inc.
Published: 2008-01-24
License: https://open.fda.gov/license/

B & K Medical Systems, Inc. / initiated 2008-01-24 / Terminated / root cause: manufacturing process

FDA source

B & K Medical Systems, Inc. began a recall of B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887 on 2008-01-24. The reason FDA records is "Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization". 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-1140-2008
Status: Terminated
Initiated: 2008-01-24
Posted: 2008-06-10
Terminated: 2008-06-23
Recalling firm: B & K Medical Systems, Inc.
Product: B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: B-K Medical issued letter notification on 1/23/08 to accounts via Fed Ex, advising them not to use the unit until a representative can inspect and exchange, if unit is found defective. Instructions are also provided to continue use of the device with a sterile cover until site visit.
Quantity in commerce: 7
Distribution: USA Distribution: MA, MI, PA, TX, and OR.
Product codes and lots: Serial Numbers: 1864742, 1869148, 1869619, 1870824, 1870825, 1872061, and 1875317.

Product code IYN

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)