Recall Z-0180-2010 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific CRM Corp
Guidant LATITUDE Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The LATITUDE Patient Management system enables physicians to periodically monitor both patient and device status remotely. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transf
| Date | Nov 12, 2009 (initiated Aug 7, 2009) |
| Status | Terminated |
| Reason | The L ATITUDE communicator (Model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor afer initial setup. The issue has been resolved. If any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to LATITUDE after the patient's communicator calls in to Boston Scientific's servers. It |
| Root cause | Software design |
| Action | Boston Scientific used phone calls as the delivery method for these communications. The communication began August 6, 2009 for the original 6 patients affected. Notifications via phone calls to additional patients affected began on August 17, 2009. Direct questions about the recall to the LATITUDE Customer Service by calling 1-651-582-4000. |
| Quantity | 97 |
| Distribution | Nationwide Distribution -- AZ, AR, CA, CT, FL, GA, IL, IN, MA, MO, NV, NJ, NY, OH, OR, PA, SC, TX, UT, VA and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.