| | Class 2 Recall
Latitude Patient Management System Communicator |  |
| Date Posted |
April 20, 2012 |
| Recall Number |
Z-1445-2012 |
| Product |
Boston Scientific LATITUDE® Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, Made in Malaysia. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. |
| Code Information |
219329
218900
219316
219304
219367
219372
218958
218842
|
Recalling Firm/
Manufacturer |
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul, Minnesota 55112-5700 |
| Consumer Instructions |
Contact the recalling firm for information |
Reason for
Recall |
Boston Scientific LATITUDE¿ Patient Management System Communicators were shipped to the incorrect patients.
|
| Action |
The patients were notified via phone starting on 2/24/12 that their communicator will not be able to activate successfully and that their communicator and sensors will be replaced. If the patient could not be reached via phone or voice mail, a Boston Scientific letter dated 2/29/12 was sent to the patient. The letter described the problem, explained What is a LATITUDE Communicator and What should you do. Questions were directed to Patient Services at (866) 484-3268. |
| Quantity in Commerce |
8 |
| Distribution |
Nationwide Distribution, including the states of: AL, CA, FL, IL, IN, MO, NJ, NY, OH, OR, TX VA, and WA. |
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