—#70919

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.

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031552
Affected lot / code info: 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.

Why it was recalled

HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-05-29
Posted by FDA: 2008-09-16
Terminated: 2011-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70919. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.