Recall Z-1011-2015 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging
| Date | Jan 26, 2015 (initiated Nov 12, 2014) |
| Status | Terminated |
| Reason | Unintended detector and gantry movement due to software issues. |
| Root cause | Software design |
| Action | Philips Healthcare sent an Urgent - Field Safety Notice dated November 4, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Philips is advising the customers/users to retain a copy of this Field Safety BY CUSTOMER I USER Notice with the equipment Instruction for Use, until further notice. Problem #1: Philips is advising the customer/user to perform the following workaround prior to the implementation of the field safety correction, to avoid contact between the detector and the head holder as describe above in Problem |
| Quantity | 1064 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Leban |
| 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 |