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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable biopsy plate

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 Class 2 Recall
Disposable biopsy plate
see related information
Date Posted February 15, 2007
Recall Status1 Open
Recall Number Z-0518-2007
Recall Event ID 37263
Premarket Notification
510(K) Numbers
K041695  K052585 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part: Disposable Biopsy Plate, part U1-150131, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils and with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The disposable biopsy plate for use with GE coils is packaged and sold as a part of catalogue U1-160051, U1-150190, U1-150131. The disposable biopsy plate for use with OEM coils is packaged and sold as part of catalogue U1-150226, U1-150190, U1-155068, U1-160016, U1-160052, U1-160085, U1-160166, U1-160175, 2412158, 2416938, 2417842, and U1-150131.
Code Information All lot codes
Recalling Firm/
Manufacturer
USA Instruments Incorporated
1515 Danner Dr
Aurora, Ohio 44202-9273
For Additional Information Contact Robert B. Smith
800-582-2145
Manufacturer Reason
for Recall
The packaging used for the Breast Biopsy plate may exhibit small holes or tears
FDA Determined
Cause 2
TRAINING: Employee Error
Action The recalling firm notified consignees via certified letter, dated 1/31/07.
Quantity in Commerce Approximately 2200 units for all products being recalled
Distribution Worldwide, including USA, Canada, Mexico, Argentina, Australia, Austria, Bhutan, Brazil, Chile, China, Denmark, Finland, Germany, Great Britain, Greece, Guatemala, Honduras, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Panama, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, and Turkey.
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 = LNH and Original Applicant = USA INSTRUMENTS, INC.
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