| | Class 2 Device Recall Diagnostic Ultrasound Transducer |  |
| Date Initiated by Firm | March 16, 2006 |
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| Date Posted | May 09, 2006 |
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| Recall Status1 |
Terminated 3 on October 12, 2006 |
| Recall Number | Z-0856-06 |
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| Recall Event ID |
34900 |
| Product Classification |
Diagnostic Ultrasound Transducer - Product Code IYN
|
| Product | Convex Array Transducer used with B-K Ultrasound Scanners
Model number: 8667 |
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| 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 |
| FEI Number |
1000305740
|
Recalling Firm/
Manufacturer |
B & K Medical Systems, Inc.
250 Andover St
Wilmington
MA
01887-1048
|
| For Additional Information Contact | Lars Larsen
978-988-1078 |
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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
|
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FDA Determined
Cause 2 | Other |
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| 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 . |
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| Quantity in Commerce | 28 units |
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| Distribution | CA,CT, FL, MD, ME, MN, MS, NY, OH, RI, SD, TX, VA |
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| Total Product Life Cycle | TPLC Device Report |
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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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