Recall Z-0785-2014 ยท IZJ Camera, X-Ray, Fluorographic, Cine Or Spot
Philips Medical Systems (Cleveland) Inc
ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
| Date | Jan 17, 2014 (initiated Dec 4, 2013) |
| Status | Terminated |
| Reason | The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies in the fork weldment. |
| Root cause | Nonconforming Material/Component |
| Action | On October 30, 2013 & December 4, 2013, the firm sent Urgent Medical Device Recall letters to their customers. |
| Quantity | 255 units |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AL, AR, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TN, TX, VA, VT, WA, WI & WV; and Internationally to: Austria, Belgium, Canada, Denmark, Germany, Great |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913471 | CIRRUS GAMMA CAMERA Adac Laboratories, Oct 23, 1991 |