08
Apr
2009

Cl Il Cerner HNA Classic PathNet Blood Bank Donor

0

Company:Cerner Corp.
Date of Enforcement Report 4/8/2009
Class:ll

PRODUCT
Cerner HNA Classic PathNet Blood Bank Donor, versions 306 and 015, 510(k) #BK950055, Recall # B-0677-09

REASON
Software with a glitch or defect was distributed.

RECALLING FIRM/MANUFACTURER
Cerner Corp., Kansas City, MO, by website on March 11, 2009, e-mailed on March 12, 2009 and registered mail on March 13, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
44 units

DISTRIBUTION
Nationwide, Saudi Arabia and Singapore

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.

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