Jun

2001

Electronic Data Systems (EDS) Class II

Company: Electronic Data Systems (EDS)Enforcement Report Date: 6/13/01
Class: II

PRODUCT:
Defense Blood Standard System, Blood Bank Computer Software, – In use at 79 military facilities. Recall # B-897-1.

REASON:
Due to a defect in computer software, expired blood products that were returned, and units that were received at out of spec temperatures, were not quarantined.

CODE:

Versions 3.00 and 3.01.

MANUFACTURER:
Electronic Data Systems (EDS), Herndon, VA.

RECALLED BY:
Department of Defense, Composite Health Care System II, DBSS Project Office, Falls Church, VA., sent a technical bulletins to seventy nine military facilities on July 21, 2000. Firm initiated recall is complete.

DISTRIBUTION:
Nationwide, Japan, Italy, England, Germany, South Korea, Guam.

QUANTITY:
79 units.

About the author

Amy Sellers

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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Electronic Data Systems (EDS) Class II

Amy Sellers

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