Philips MobileDiagnost wDR Recalled for Non-Compliant Instructions for Use
Philips Healthcare is recalling MobileDiagnost wDR systems because the Instructions for Use fail to comply with a Federal standard regarding generator value tolerance levels.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation issue (Instructions for Use non-compliance) with no reported injuries, illnesses, or mechanical failures, fitting the rubric for documentation issues.
Plain-English summary
Philips Healthcare Inc. is recalling the MobileDiagnost wDR mobile digital radiography X-Ray system. The recall involves 240 systems distributed in the United States, including one system in Puerto Rico. The product is intended for use by qualified doctors or technologists for diagnostic radiographic exposures of various body parts.
The recall was initiated because the Instructions for Use (IFU) for the MobileDiagnost wDR fail to comply with a Federal standard. Specifically, the IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3). This is a documentation and labeling compliance issue rather than a reported mechanical defect or injury.
Healthcare facilities and users of the affected systems should contact Philips Healthcare Inc. for further instructions on how to resolve the non-compliance in the documentation. The recall number is Z-1964-2013.
The recalled product
- Product
- 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
- Manufacturer
- Philips Healthcare 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 (1)
- System Code - 712001
Distribution
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