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U.S. Department of Health and Human Services

Class 2 Device Recall Diagnostic Ultrasound Transducer

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  Class 2 Device Recall Diagnostic Ultrasound Transducer see related information
Date Initiated by Firm March 16, 2006
Date Posted May 09, 2006
Recall Status1 Terminated 3 on October 12, 2006
Recall Number Z-0856-06
Recall Event ID 34900
510(K)Number K991937-K000567-K024236-K043524-K043554  
Product Classification Diagnostic Ultrasound Transducer - Product Code IYN
Product Convex Array Transducer used with B-K Ultrasound Scanners
Model number: 8667
Code Information 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
Recalling Firm/
Manufacturer		 B & K Medical Systems, Inc.
250 Andover St
Wilmington MA 01887-1048
For Additional Information Contact Lars Larsen
978-988-1078
Manufacturer 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
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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