Company: Sunquest Information Systems, Inc.,
Date of Enforcement Report 2/13/2008
Class:ll
PRODUCT
Sunquest Laboratory Blood Bank and Blood Donor, version 6.0.1 and 6.0.2, Recall # B-0663-08
REASON
Software, with a glitch or defect, was distributed.
RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tucson, AZ, by e-mail on December 14. 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
283 units
DISTRIBUTION
Nationwide and Internationally
Being Agile & Yet Compliant (Public)
Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!
3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.
Lead Instructor: Mike Russell
Next public offerings:
IEC 62304 and other emerging standards for Medical Device and HealthIT Software
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Medical Device Cybersecurity (Public or Private)
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2-days onsite with group exercises, quizzes, examples, Q&A.
Instructor: Dr Peter Rech, 2nd instructor (optional)
Next public offering: TBD
