Recall Z-0848-2010 ยท KPR System, X-Ray, Stationary
Philips Medical Systems North America Co. Phillips
BuckyDiagnost. General Radiography and Tomography examination of patients in supine, seated, or standing positions.
| Date | Mar 23, 2010 (initiated Jan 21, 2010) |
| Status | Terminated |
| Reason | Device failed to display appropriate labels indicating Radiation Symbol along with the required wording. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Urgent - Field Safety Notice letters, dated January 20 & 21, 2010, were sent to customers. The letter identified the affected products, gave a description of the problem & the hazard involved, stated how to identify affected products, actions to be taken by the customer or user, and actions planned by the firm. Customers are to make sure that the relevant safety precautions are observed and check their operators console (EEC) if the labeling is present as shown in the drawing. If the labeling is missing, a Philips rep should be contacted. For further information or support concerning the i |
| Quantity | 16 units |
| Distribution | Devices were distributed through out the US in the following states: AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, WI, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945278 | PHILIPS BUCKY DIAGNOST FAMILY Philips Medical Systems North America, Inc., Dec 14, 1994 |