Recall Z-1022-2016 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
| Date | Dec 17, 2015 |
| Status | Terminated |
| Reason | The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause |
| Root cause | Software design |
| Action | On 12/22/2015, the firm sent Customer Information Letters to their consignees. The letter identified the product, problem and actions to be taken by the customers. |
| Quantity | 427 units |
| Distribution | Worldwide Distribution-US (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, 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 in DC and PR and in the countries of Algeria, Ar |
| 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 |