FDAFDA · Food and drugs·Recall number Z-1339-2013
LATITUDE¿ Patient Management System, Model 6488, Version 7.3. 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.
Published May 29, 2013 · Recall initiated: April 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.
What to do
Voluntary: Firm initiated · FAX
Recall details
- Manufacturer
- Boston Scientific CRM Corp
- Distributor
- Nationwide Distribution including DC and PR
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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