| Class 2 Device Recall Large grid biopsy plate | |
Date Initiated by Firm | January 31, 2007 |
Date Posted | February 15, 2007 |
Recall Status1 |
Terminated 3 on April 13, 2012 |
Recall Number | Z-0519-2007 |
Recall Event ID |
37263 |
510(K)Number | K041695 K052585 |
Product Classification |
biopsy plate - Product Code LNH
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Product | The recalled product is the Large grid biopsy plate, part #2414797. The biopsy plate is labeled in part: Large Grid Biopsy Plate, part 2414797, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile.
The breast biopsy plate is used with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The large grid biopsy plate is packaged and sold as a part of catalogue 2414798 and 2415277. |
Code Information |
All lot codes |
Recalling Firm/ Manufacturer |
USA Instruments Incorporated 1515 Danner Dr Aurora OH 44202-9273
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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 | Other |
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 |
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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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510(K) Database | 510(K)s with Product Code = LNH
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