High FDA (Devices)·Z-0508-2015·Announced 2014-12-24

Philips MobileDiagnost wDR Recalled for Unintended Radiation Exposure Risk

Philips Medical Systems is recalling MobileDiagnost wDR units due to a potential for unintended radiation exposure during start-up.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of unintended radiation exposure, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Philips Medical Systems, Inc. is recalling the MobileDiagnost wDR (WmDR 1.1) mobile X-ray system. The recall is issued because, in special cases, an unintended exposure could occur during the start-up of the device.

The affected units are intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. The recall covers 247 units in the US and 1 unit in Puerto Rico, with worldwide distribution to numerous other countries.

Healthcare facilities should contact Philips Medical Systems for instructions on how to address the issue. The specific serial numbers affected are listed in the official recall documentation.

The recalled product

Product: 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 lyi
Manufacturer: Philips Medical Systems, Inc.
Category: Medical Device — Diagnostic Imaging
Hazard: radiation-exposure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial Numbers: SN12000024
SN12000166
SN13000081
SN13000127
SN13000140
SN13000141
SN13000143
SN13000144
SN13000145
SN13000167
SN13000168
SN13000169
SN13000196
SN13000199
SN13000200
SN13000201
SN13000202
SN13000203
SN13000204
SN13000205

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically:

Same manufacturer · Philips Medical Systems, Inc.

See all →

Moderate
Philips Medical Systems Recalls Foot Switches for Bent Pedal Defect
FDA (Devices) · 2016-04-06
Moderate
Philips MultiDiagnost Eleva Foot Switches Recalled for Bent Pedal Defect
FDA (Devices) · 2016-04-06
Severe
Philips IntelliVue Information Center iX Software Recall for Alarm Failure
FDA (Devices) · 2015-12-16
High
Philips INTEGRIS Cardio System Ceiling Suspension Recall
FDA (Devices) · 2015-12-09
High
Philips Allura BiPlane Ceiling Suspension System Recall for Fall Risk
FDA (Devices) · 2015-12-09

Same hazard · radiation exposure