Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ing
FDA device recall Z-1359-2015 · posted 2015-04-01 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted.
- Action taken
- Philips sent an Customer Information letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They informed their customers that they should refrain from using Multi Planar Reconstruction (MPR) derived images for identifying the absolute position of the intervention for feet-first patient orientation. A Philips Field Service Engineer will contact you to schedule the software installation at your site. If you need any further information or support concerning this issue, please contact your local Philips representative. Philips apologizes for any inconveniences caused by this problem. For further questions please call (440) 483-7600.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 424 units
- Distribution
- Worldwide Distribution - Nationwide Distribution to the states of : AR, AZ, CA, CT, DE, FL, GA, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VT, WV and W
- Date initiated
- 2015-02-05
- Date posted
- 2015-04-01
- Date terminated
- 2016-08-25
- 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 |
| PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM (K033326) | Philips Medical Systems, Inc. | 2003-10-29 |