Recall Z-1481-2013 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
| Date | Jun 5, 2013 (initiated Apr 25, 2013) |
| Status | Terminated |
| Reason | Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly. |
| Root cause | Other |
| Action | Philips Healthcare sent an Urgent Medical Device Correction letter dated April 26, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customer were not required to take any specific action. Customers who need further information or support concerning the affected product, they should contact their local lPhilips representative or local Philips Healthcare office. For North Americ and Canada they should contact the Customer Care Solutions Center (1-800-722-9377, option 5). For questions regarding this recall call 440-483-7600. |
| Quantity | 505 units |
| Distribution | Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV & WY. Internationally to Australia, Austria, Bahrain, Belgium, Brazil, Canada, China, Czec |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062298 | APOLLO GAMMA CAMERA SYSTEM Adac Laboratories, Aug 23, 2006 |