Recall Z-1074-2014 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.
| Date | Feb 24, 2014 (initiated Dec 19, 2013) |
| Status | Terminated |
| Reason | Three problems were reported to the firm: When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly causing an inappropriate rotation orbit calculation. When the acquisition was started and the detectors began to move into position, the incorrect calculation resulted in the detectors coming in contact with the patient. As |
| Root cause | Software design |
| Action | On 12/19/2013 the firm sent Field Safety Notices to their customers. |
| Quantity | 1,143 units |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV & WY, and the countries of Algeri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080927 | BRIGHTVIEW VCT IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc., Apr 11, 2008 |