Recall – Patient Monitoring System software error

Company: GE Healthcare, LLC
Date of Enforcement Report: 11/29/2018
Class II:

PRODUCT
Patient Monitoring System used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

Recall Number: Z-0519-2019 (Dash 3000), Z-0520-2019 (Dash 4000), Z-0521-2019 (Dash 5000), Z-0522-2019 (Solar 8000i), Z-0523-2019 (Solar 8000M), Z-0524-2019 (Solar 9500)

REASON
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 8/31/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
– Approximately 182,640 monitoring systems for Dash 3000/4000/5000

– Approximately 73,673 Solar 8000i and 8000M monitoring systems

– Approximately 3,864 Solar 9500 monitoring systems

DISTRIBUTION
U.S. Nationwide and International

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?
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