FDA Medical Device Recalls (openFDA)
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 number
- Z-2013-2008
- Recalling firm
- Philips Medical Systems
- 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.
- Status
- Terminated
- Initiated
- 2008-05-29
- Posted
- 2008-09-16
- Terminated
- 2011-08-18
- 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 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K031552"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28