Philips Medical Systems is recalling 3,011 units of the Azurion Interventional Fluoroscopic X-ray System (Software Versions R1.0, R1.1, and R1.2) due to a defect that can cause a sudden loss of imaging functionality. This recall affects various models including 722063, 722064, 722067, 722068, 722078, and 722079, which are used to guide doctors during complex surgeries such as vascular and neuro procedures. The systems may experience a loss of X-ray imaging or take an unexpectedly long time to perform a 'cold restart,' which can delay critical medical interventions. Healthcare providers should contact Philips immediately to address these software-related performance issues.
The sudden loss of X-ray imaging during a live surgical procedure can leave medical teams unable to see the patient's internal structures, potentially leading to surgical errors or significant delays. If the system requires a lengthy cold restart during a time-sensitive cardiovascular or neuro procedure, the delay in treatment could result in serious patient harm.
Manufacturer notification and guidance
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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