April 8, 2020
Company: Ra Medical Systems, Inc. Date of Enforcement Report: 4/8/2020 Class II PRODUCT Pharos Excimer Laser, Model: EX-308 – Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the invisible region...
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Company: Haemonetics Corporation Date of Enforcement Report: 4/8/2020 Class II PRODUCT TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies Recall Number: Z-1617-2020 REASON Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to...
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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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