Dec

2008

Inc, Cl Il Hologic

Company: Hologic, Inc
Date of Enforcement Report 12/31/2008
Class:ll

PRODUCT
Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software, Recall # Z-0449-2009

REASON
Software error may lead to a high estimate of major fracture probability.

RECALLING FIRM/MANUFACTURER
Hologic, Inc., Bedford , MA , by telephone on September 23-24, 2008 and by letter on September 25, 2008. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
15 software CD’s

DISTRIBUTION
CO, MA, MN, NM, NY, NC, OR, OH, PA, TX, and UK

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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Inc, Cl Il Hologic

Amy Sellers

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