Philips Medical Systems Biopsy Guide Starter Kits C5-2 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AR, CO, DE, GA, IN, MD, MA, MI, NY, VA, WA