Recall Z-2015-2008 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Medical Systems
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.
| Date | Sep 16, 2008 (initiated May 29, 2008) |
| Status | Terminated |
| Reason | HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use. |
| Root cause | 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 res |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031552 | MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS Medison America, Inc., May 30, 2003 |