Recall Z-0847-2010 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems North America Co. Phillips
DigitalDiagnost. General radiographic examinations and applications wherever a solid state X-ray imaging device can be used.
| 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 | 117 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
| K982795 | PHILIPS BUCKY VISION Philips Medical Systems, Inc., Nov 24, 1998 |