Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column,

FDA device recall Z-0508-2015 · posted 2014-12-16 · Terminated

Recall details

Recalling firm

Philips Medical Systems, Inc.

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.

Action taken

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

Status

Terminated

Product code

IZL

Quantity affected

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,

Date initiated

2014-04-08

Date posted

2014-12-16

Date terminated

2018-05-31

Location

Andover, MA

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