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U.S. Department of Health and Human Services

Class 2 Device Recall LATERAL BIOPSY PLATE, For use with the Liberty 9000 8 channel breast coil

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 Class 2 Recall
LATERAL BIOPSY PLATE, For use with the Liberty 9000 8 channel breast coil
see related information
Date Posted February 15, 2007
Recall Status1 Open
Recall Number Z-0505-2007
Recall Event ID 36866
Premarket Notification
510(K) Numbers
K041695  K052585 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent to customers in the following configurations: 1) The plate is purchased in sets of 5 as part number E8800BG 8 Channel Breast Biopsy Lateral Grids (pack of 5 grids) or 2) the plate is purchased in pairs with the following part numbers: M3087JG, which contains Liberty 9000 8-Channel Breast Coil, 2 plates and a manual; G3087JH, which contains 2 plates and a manual; M3335LA, which contains a 3T HD 8 channel Vibrant Breast Array, 2 plates and a manual.
Code Information ''LOT 6318910'', expiration date 09/2007.
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 Customers were notifed by certified letter, dated 11/28/06.
Quantity in Commerce 250 units
Distribution Nationwide.
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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