Recall Z-1598-2015 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
| Date | May 12, 2015 (initiated Mar 13, 2015) |
| Status | Terminated |
| Reason | During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition. |
| Root cause | Employee error |
| Action | Philips sent an Customer Information letter dated March 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to : 1. Do not lubricate the clutch(es) with oil, grease or any other type of lubricant.. 2. Follow product Instructions For Use (IFU), CARDIO. SOLUS, ADAC VERTEX, AND ADAC VERTEX PLUS WITH ATLAS USERS MANUAL, 9201-0227E-ENG, REV A- General Precautions that instructs user to monitor the patient during scanning. 3. Follow product Instructions For Use (IFU), CARDIC, SOLUS, ADAC V |
| Quantity | 918 units |
| Distribution | Worldwide Distribution - US (nationwide) including Puerto Rico and to the states of : AL, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV., and to the count |
| FDA record | Open on fda.gov |