Boston Scientific LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Ha
FDA device recall Z-1445-2012 · posted 2012-04-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific CRM Corp
- Reason for recall
- Boston Scientific LATITUDE Patient Management System Communicators were shipped to the incorrect patients.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LWS
- Quantity affected
- 8
- Distribution
- Nationwide Distribution, including the states of: AL, CA, FL, IL, IN, MO, NJ, NY, OH, OR, TX VA, and WA.
- Date initiated
- 2012-02-24
- Date posted
- 2012-04-20
- Date terminated
- 2012-08-02
- Location
- Saint Paul, MN
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