Recall Z-0508-2015 ยท IZL System, X-Ray, Mobile
Philips Medical Systems, Inc.
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.
| Date | Dec 16, 2014 (initiated Apr 8, 2014) |
| Status | Terminated |
| Reason | In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur. |
| Root cause | Software design |
| 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 in |
| Quantity | 247 in US, 1 in Puerto Rico |
| Distribution | 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, Austral |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111725 | MOBILEDIAGNOST WDR Sedecal., Sa., Jul 19, 2011 |