Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Recalled by Philips Healthcare Inc. Due to The Instructions for Use (IFU) for the MobileDiagnost...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Healthcare Inc. directly.
Affected Products
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.
Quantity: 240 systems US -- 1 system within Puerto Rico
Why Was This Recalled?
The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Healthcare Inc.
Philips Healthcare Inc. has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report