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Terminated

Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

FDA Recall Z-0508-2015 · Posted 2014-12-16

Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeIZL
Date Initiated2014-04-08
Date Terminated2018-05-31
Product Quantity247 in US, 1 in Puerto Rico

Reason for Recall

In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.

Firm Action

Philips Healthcare sent an Important Electronic Product Radiation Warning letters dated April 8, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter alerts customers of the product defect and advises customers of Philips' plan to update the ATP software. A Philips Service Engineer will contact the customer when the Field Action Kit is released for installation. A customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance. Customers with questions about this issue can contact their local Philips representative or Philips Healthcare office, or call the Customer Care Solutions Center at 800-722-9377, Option 5. Callers should reference Field Correction Order FCO-71200109.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI.,and the countries of : Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Iraq, Ireland, Italy, Jordan, Liberia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Arab Emirates and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111725MOBILEDIAGNOST WDRSedecal., Sa. · 2011-07-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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