A Division of Tyco Healthcare ClassII Radionics

Company: Radionics, A Division of Tyco Healthcare
Date of Enforcement Report: 11/21/01
Class: II

PRODUCT
Radionics XKnife RT Software, Recall # Z-0275-2.

REASON
Software error may cause incorrect jaw settings for a record/verify system.

CODE
Version 1.02 and lower.

RECALLING FIRM/ MANFACTURER
Radionics, A Division of Tyco Healthcare, Billerica, MA, by telephonebetween 9/17/2001 and 18/01. Firm initiated recall is ongoing.

PRODUCT
51.

DISTRIBUTION
Nationwide and International.

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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