510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-0847-2010

DigitalDiagnost. General radiographic examinations and applications wherever a solid state X-ray imaging...

Philips North America LLC / initiated 2010-01-21 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

Philips Medical Systems North America Co. Phillips began a recall of DigitalDiagnost. General radiographic examinations and applications wherever a solid state X-ray imaging device can be used on . The reason FDA records is "Device failed to display appropriate labels indicating Radiation Symbol along with the required wording". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0847-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
DigitalDiagnost. General radiographic examinations and applications wherever a solid state X-ray imaging device can be used.
Product code
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall
Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.
Root cause tag
labeling and UDI
FDA 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 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.
Product codes and lots
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.