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U.S. Department of Health and Human Services

Class 2 Device Recall BK Medical

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 Class 2 Recall
BK Medical
see related information
Date Posted June 10, 2008
Recall Status1 Terminated on June 23, 2008
Recall Number Z-1140-2008
Recall Event ID 46394
Premarket Notification
510(K) Numbers
K024236  K043524 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887
Code Information Serial Numbers: 1864742, 1869148, 1869619, 1870824, 1870825, 1872061, and 1875317.
Recalling Firm/
B & K Medical Systems, Inc.
250 Andover St
Wilmington, Massachusetts 01887-1048
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = B-K MEDICAL A/S