Class 2 Device Recall DigitalDiagnost

• Date Initiated by Firm: January 21, 2010
• Date Posted: March 23, 2010
• Recall Status: Terminated on January 25, 2011
• Recall Number: Z-0847-2010
• Recall Event ID: 54641
• 510(K)Number: K982795
• Product Classification: Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
• Product: DigitalDiagnost. General radiographic examinations and applications wherever a solid state X-ray imaging device can be used.
• Code Information: Site Numbers: 102713, 102717, 102719, 504953, 505038, 541571, 545001, 545002, 41443853, 41443865, 41445819, 42380669, 42381462, 42456359, 42457219, 42495269, 42670799, 42670972, 42735547, 42800813, 42861810, 42868030, 43110437, 43136324, 43194952, 43249471, 43352116, 43352353, 43352366, 43352389, 43352789, 43453754, 43453757, 43622123, 43679113, 43680694, 43709240, 43718896, 43720045, 43721194, 43721661, 43902737, 43903999, 43985064, 44038310, 44067181, 44150484, 44229312, 44281712, 44291382, 44329875, 44428253, 44428523, 44428969, 44429963, 44429977, 44430170, 44430274, 44430275, 44430281, 44560894, 44562813, 44618188, 44640603, 44649438, 44650792, 44653666, 44654700, 44654760, 44671872, 44671873, 44891779, 44925674, 44945654, 45121894, 45142402, 45147685, 45168336, 45168583, 45168651, 45219739, 45312115, 45369771, 45369772, 45369773, 45404482, 45412925, 45414286, 45420726, 45427571, 45428681, 45441410, 45464313, 45485736, 45517411, 45543336, 45592706, 45593671, 45605694, 45631115, 47144505, 47180980, 47325696, 47401982, 47402790, 47403052, 47463075, 47552050, 47615224, 47616409, 47624694, 48433840, 48434300, 49001785, 49037133, 49311857, and 49579551.
• Recalling Firm/ Manufacturer: Philips Medical Systems North America Co. Phillips; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Philips Healthcare Call Center; 800-722-9377 Ext. 5
• Manufacturer Reason for Recall: Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.
• FDA Determined 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 issue, a Philips rep should be contacted at 800-722-9377.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MQB