Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by compute
FDA device recall Z-0831-2014 · posted 2014-01-27 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- An artifact that resembles thrombus may appear on the image.
- Action taken
- Philips sent an Field Safety Notice dated July 15, 2013, to all US customers via certified mail. Market representatives will distribute the letter internationally. The letter identified the product the problem and the action needed to be taken by the customers. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.For North America and Canada, contact the Customer Care Solutions Center (1"800-722"9377,Option 5: Enter Site 10 or follow the prompts). This notice has been reported to the appropriate Regulatory Agency Philips apologizes for any inconveniences caused by this problem
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 506
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and the states AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SC, TX, VT, WA, and WV.,
- Date initiated
- 2013-07-16
- Date posted
- 2014-01-27
- Date terminated
- 2014-09-19
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRILLIANCE VOLUME (K060937) | Philips Medical Systems (Cleveland), Inc. | 2006-06-05 |