Mar

2012

Cl lll LATITUDE Patient management System

Company:Boston Scientific CRM Corp
Date of Enforcement Report 3/14/12
Class lll:

PRODUCT
LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database. Recall # Z-1096-2012

REASON
Patients are not able to perform setup. There is no risk to health associated with this issue.

RECALLING FIRM/MANUFACTURER
Boston Scientific CRM Corp., Saint Paul, MN, by telephone beginning on December 19, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1 units

DISTRIBUTION
Nationwide

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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Cl lll LATITUDE Patient management System

Amy Sellers

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