November 17, 2021
Company: Philips North America Llc Date of Enforcement Report: 11/17/2021 Class II PRODUCT Philips Azurion Interventional Fluoroscopic X-Ray System Software version: 2.1.x Model numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 11/17/2021 Class II PRODUCT Hemodialysis Delivery System, Software Version 2.x. Recall Number: Z-0215-2022 REASON If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from...
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Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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