Z-0271-05

Linear Array Transducer Type: 8809

Name: Z-0271-05 Linear Array Transducer Type: 8809
Creator: B & K Medical Systems Inc.
Published: 2004-11-12
License: https://open.fda.gov/license/

B & K Medical Systems, Inc. / initiated 2004-11-12 / Terminated / root cause: sterility

FDA source

B & K Medical Systems Inc. began a recall of Linear Array Transducer Type: 8809 on 2004-11-12. The reason FDA records is "Defect at probe tip may effect sterilization and electrical safety". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0271-05
Status: Terminated
Initiated: 2004-11-12
Posted: 2004-12-02
Terminated: 2005-01-18
Recalling firm: B & K Medical Systems, Inc.
Product: Linear Array Transducer Type: 8809
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Defect at probe tip may effect sterilization and electrical safety
Root cause tag: sterility
FDA root cause: Other
Action: BK Medical Wilmington, MA notified accounts by letter dated 11/ 12 /04 via UPS Overnight.. Accounts are requested to return the unit.
Quantity in commerce: 17 units
Distribution: CA, CO, CT, FL, LA, GA, NJ, NY, VA, VT
Product codes and lots: Serial Numbers: 1831984 1831985 1831986 1831987 1831989 1831990 1831992 1832004 1832007 1844219 1844235 1844239 1844240 1844241 1847871 1847875 1847889

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)