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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Philips Medical Systems, Inc.
- Hazard
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
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