| Class 2 Device Recall Biopsy Guide Starter | |
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
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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
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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 |
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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 = IYN
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