510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-2013-2008

Biopsy Guide Starter Kits C5-2 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound...

Philips North America LLC / initiated 2008-05-29 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

Philips Medical Systems began a recall of 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 on . The reason FDA records is "HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2013-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
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.
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall
HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.
Root cause tag
labeling and UDI
FDA 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 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
79 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.
Product codes and lots
C5-2 Part No. 989605353731; C5-2 lot #'s : 6503, 6536, 6536, 6693, 6801, 6978, 7175, 7861, 7861, 7982, 7861, 8053, 8286 and 9155. SN # ranges: 123-152, 153-167, 178-187, 168-177, 188-197, 198-207, 208-222, 223-224, 233-247, 248-251, 225-232, 252-254, 255-264 and 265-269.