Recall Z-0450-2015 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
| Date | Dec 1, 2014 (initiated Nov 4, 2014) |
| Status | Terminated |
| Reason | Software issues |
| Root cause | Software design |
| Action | Philips Healthcare sent an URGENT - Field Safety Notice Medical Device Correction letter dated November 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice 88200485 is intended to inform you about: " what the issues are and under what circumstances they can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct these issues. If you need any further information or support concerning these |
| Quantity | 85 |
| Distribution | Worldwide Distribution - USA including the states of AR, CA, FL, GA, ID, LA, ME, MI, MN, MO, MS, NJ, NY, OH, OK, PA, and TX. Government Facilities: AR, FL, MN, OH, and OK. and the countries of: Canada, China, Denmark, Germany, Italy, South Korea, Spain, Sweden, Switzerland, Taiwan, and United Kingdo |
| FDA record | Open on fda.gov |