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.
- Company
- Philips Medical Systems
- Recall Initiated
- May 29, 2008
- Posted
- September 16, 2008
- Terminated
- August 18, 2011
- Recall Number
- Z-2014-2008
- Quantity
- 35 units
- Firm Location
- Andover, MA
Reason for Recall
HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.
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.
Lot / Code Info
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.
Root Cause
Labeling design
Action Taken
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.