Company: AGFA. Corp.
Date of Enforcement Report:2/12/2014
Class lI:
PRODUCT
IMPAX RIS QDOC 5.8 Recall Number Z-0919-2014
REASON
Patient name displayed (printed) on the Patient Report was the wrong patient name.
RECALLING FIRM/MANUFACTURER
AGFA. Corp., Greenville, SC. on 1/8/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
14
DISTRIBUTION
CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
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Being Agile & Yet Compliant (Public)
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3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.
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IEC 62304 and other emerging standards for Medical Device and HealthIT Software
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TBD
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
