Cerner Corporation Class II

Company: Cerner Corporation
Date of Enforcement Report: 5/4/05
Class: II

PRODUCT
HNA Classic 306 Patient Manager Blood Bank Software. Recall # B-0843-5.

REASON
Defects in the design of blood bank software could result in loss of patient antibody information.

CODE
Revision 159 and higher.

RECALLING FIRM/MANUFACTURER
Cerner Corporation, Kansas City, MO, by telephone calls beginning on 2/25/05, and completed by March 1, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
246 software packages.

DISTRIBUTION
Nationwide and Internationally.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

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IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.