Philips Medical Systems is recalling 216 CombiDiagnost R90 1.0 and 1.1 Radio Fluoroscopy systems because the viewer may incorrectly display radiography images from a previous patient instead of the current one. This defect can be identified by noticeable differences in the image content, format, or size during a medical examination. The recall affects units with software version 1.1.1 or higher distributed across 16 U.S. states. Philips is notifying customers by letter to address this software-related issue.
The display of a previous patient's images during a live procedure could lead to a misdiagnosis or incorrect medical treatment based on the wrong clinical information. This poses a risk of harm to patients undergoing fluoroscopy examinations if the medical staff does not recognize the imagery is incorrect.
Manufacturer initiated recall following notification by letter.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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