October 18, 2018
Company: GE Healthcare, LLC Date of Enforcement Report: 10/24/2018 Class II: PRODUCT Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher. Recall Number: Z-0195-2019 REASON Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC, Waukesha, WI on...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 10/24/2018 Class II: PRODUCT Atellica Sample Handler Prime (SMN 11069001). The Atellica” Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. Recall Number: Z-0189-2019 REASON Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: Reagent Lock may...
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Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to by Sep 25, 2019 if possible!

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