Feb

2000

DadeMicroscan Pediatric Therapy Software Class II

Amy Sellers

News

recall

REASON

Potential for incorrect Pediatric Reports–A software problem.

PRODUCT

a) 2-way MainFrame Interface Software Version 22.20;

b) Pediatric Therapy Guide Version 4.10.

Recall #Z-405/406-0.

CODE

Part Numbers: 9800-2666 and 9800-0630;

Catalog Numbers: B1018-15 and B1011-30.

MANUFACTURER

Dade Microscan Inc., West Sacramento, California.

RECALLED BY

Manufacturer, by letter on February 4, 2000. Firm-initiated field correction ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

90 copies were distributed.

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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DadeMicroscan Pediatric Therapy Software Class II

Amy Sellers

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