EasyDiagnost. Multi-functional R/F systems used for general R/F, Fluoroscopy, Radiography and Angiography examinations.
FDA Recall Z-0849-2010 · Posted 2010-03-23
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Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeIXR
Date Initiated2010-01-21
Date Terminated2011-01-25
Product Quantity11 units
Reason for Recall
Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.
Firm 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.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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