Recall Z-1020-2016 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
| 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 | 677 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
| K062298 | APOLLO GAMMA CAMERA SYSTEM Adac Laboratories, Aug 23, 2006 |