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U.S. Department of Health and Human Services

Class 2 Device Recall DigitalDiagnost

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 Class 2 Recall
DigitalDiagnost
see related information
Date Posted March 23, 2010
Recall Status1 Terminated on January 25, 2011
Recall Number Z-0847-2010
Recall Event ID 54641
Premarket Notification
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, Washington 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 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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