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U.S. Department of Health and Human Services

Class 2 Device Recall Biopsy Guide Starter

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  Class 2 Device Recall Biopsy Guide Starter see related information
Date Initiated by Firm May 29, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on August 18, 2011
Recall Number Z-2015-2008
Recall Event ID 48163
510(K)Number K031552  
Product Classification Ultrasonic pulsed doppler imaging system - Product Code IYN
Product Biopsy Guide Starter Kits L9-5 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.
Code Information L9-5 Part No. 989605353761;Lot #'s : 6446, 6546, 6546, 6627, 6627, 6627, 6987, 6987, 7154, 7366, 7850 and 7983. SN # ranges: 133-162, 304-318, 319-323, 163-167, 168-177, 178-187, 188-193, 194-197, 198-212, 213-217, 218-249 and 250-264.
Recalling Firm/
Manufacturer		 Philips Medical Systems
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Beth Brouillette
978-659-4884
Manufacturer Reason
for Recall		 HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.
FDA Determined
Cause 2		 Labeling design
Action On 6/4/08, the firm sent letters to their customers via UPS. The letter informed the customers of the recall, and informed them of the following: "Customers who previously purchased and received a model C7-3 Biopsy Guide Starter Kit between November 29, 2005 and April 3, 2008 will receive a new kit at no charge, to replace the incomplete C7-3 kit previously purchased. New C7-3 kits will be distributed to affected customers by June 30, 2008. Please discard immediately the old C7-3 Biopsy Guide Kit... Customers who previously purchased and received model C5-2 and/or model L9-5 will find the respective new user manual enclosed with this letter. Please discard any old user manuals for models C5-2 and L9-5. The old C5-2 and L9-5 user manual is identified by part number 1-041-7385-02 and 1-041-7587-02 respectively. The part number is located in the lower left hand margin of the single page document." Included with the letter is a form to be faxed back to Philips indicating they have received the notice and forwarded it onto any sub accounts. If you have questions, contact your local field service representative or Beth Brouillette at 978-659-4884.
Quantity in Commerce 59 units
Distribution Products are distributed to 5 medical facilities located in NY, WA, GA, VA and MI and to 51 foreign consignees located in AR, AT, CH, CN, CO, CY, DE, DK, ES, FR, GB, GR, HK, HR, HU, IN, IT, KR, LB, LV, MA, MD, MY, NI, NL, PL, SG, SV, TH, TR, TW, ZA.
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.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = MEDISON AMERICA, INC.
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