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Terminated

B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887

FDA Recall Z-1140-2008 · Posted 2008-06-10

Recalling FirmB & K Medical Systems, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2008-01-24
Date Terminated2008-06-23
Product Quantity7

Reason for Recall

Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.

Firm 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.

Root Cause

Process control

Distribution Pattern

USA Distribution: MA, MI, PA, TX, and OR.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043524ULTRASOUND SCANNER PRO FOCUS, MODEL 2202B-K Medical A/S · 2005-01-13K024236ULTRASOUND SCANNER, TYPE 2400B-K Medical A/S · 2003-01-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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