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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 Recall
Biopsy Guide Starter
see related information
Date Posted September 16, 2008
Recall Status1 Open
Recall Number Z-2014-2008
Recall Event ID 48163
Premarket Notification
510(K) Number
K031552 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.
Code Information The C7-3 kits were not serialized and there are no batch or lot numbers available. The affected C7-3 kits were distributed between November 29, 2005 and April 3, 2008. Any kits that shipped after April 3, 2008 are not affected by this issue.
Recalling Firm/
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover, Massachusetts 01810
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 35 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 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 = IYN and Original Applicant = MEDISON AMERICA, INC.
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