August 25, 2021
Company: Philips North America LLC Date of Enforcement Report: 8/25/2021 Class II PRODUCT 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades Recall Number: Z-2314-2021 REASON When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the...
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Company: Philips Respironics, Inc. Date of Enforcement Report: 8/25/2021 Class II PRODUCT Trilogy Evo, Product numbers: BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B Recall Number: Z-2287-2021 REASON Two software issues have been identified related to pressure increase in the device: The first...
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Cybersecurity Review

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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