06

Oct

2011

LATITUDE Patient Mgmt Sys Cl ll Boston Scientific

0

Company: Boston Scientific CRM Corp.
Date of Enforcement Report 10/5/11
Class ll:

PRODUCT
Boston Scientific, LATITUDE Patient Management System Communicator, Model 6476, Boston Scientific, LATITUDE RF Communicator & Software, Model 6482. LATITUDE Communicator REF 6468 (only distributed outside the US) The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database. Recall # Z-3283-2011

REASON
A limited number of Model 6476, 6482, and 6468 (Not available in the US) LATITUDE Communicators are unable to authenticate, and thus cannot connect to the LATITUDE System. Customers are instead receiving Latitude Temporarily Unavailable (LTU) message.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific CRM Corp., Saint Paul, MN, by letter dated August 2011.
Manufacturers: Benchmark Electronics Inc, Winona, MN;
Plexus Manufacturing Sdn. Bhd., Penang, Malaysia. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
470 units

DISTRIBUTION
Nationwide and United Kingdom, France

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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