Recall Z-1605-2016 ยท NVZ Pulse Generator, Permanent, Implantable
Medtronic Inc., Cardiac Rhythm and Heart Failure
Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLink Network for viewing by the physician. The data is transmitted either through an analog telephone line, a cellular connec
| Date | Mar 31, 2016 |
| Status | Terminated |
| Reason | A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors included incorrect data on the country analog modem dial-up configuration table used to dial into the CareLink Network. This incorrect data resulted in the removal of the 0 prefix necessary for select countries as well as an incorrect alignment of phone numbers for other select cou |
| Root cause | Software design (manufacturing process) |
| Action | Medtronic sent an "Urgent Field Safety Notice" dated April 2016to their customers. The letter was addressed to Healthcare Professional. The letter identified the affected product, problem and customer actions to be taken. For questions contact your local Medtronic Representative. |
| Quantity | 5038 |
| Distribution | AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.