Recall Z-1605-2016
Medtronic Inc., Cardiac Rhythm and Heart Failure · initiated March 31, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 connection or an internet connection.
Codes / lots: Model Serial Number 2020B LPH003245P 2020B LPH004235P 2020B LPH004270P 2020B LPH004448P 2020B LPH004578P 2020B LPH006282P 2020B LPH006598P 2020B LPH006892P 2490C IJX010143A 2490C IJX010218A 2490C IJX010291A 2490C IJX010304A 2490C IJX010320A 2490C IJX010414A 2490C IJX010416A 2490C IJX010441A 2490C IJX010474A 2490C IJX010489A 2490C IJX010501A 2490C IJX010521A 2490C IJX014234A 2490C IJX014380A 2490C IJX014382A 2490C IJX014387A 2490C IJX014436A 2490C IJX014473A 2490C IJX014502A 2490C IJX014591A 2490C IJX019468A 2490C IJX019469A 2490C IJX019550A 2490C IJX019568A 2490C IJX019647A 2490C IJX019681A 2490C IJX019716A 2490C IJX019729A 2490C IJX019731A 2490C IJX019752A 2490C IJX019753A 2490C IJX019756A 2490C IJX019782A 2490C IJX019824A 2490C IJX019845A 2490C IJX019905A 2490C IJX019933A 2490C IJX019944A 2490C IJX019947A 2490C IJX020167A 2490C IJX020175A 2490C IJX020197A 2490C IJX020240A 2490C IJX020247A 2490C IJX020371A 2490C IJX020403A 2490C IJX020409A 2490C IJX020419A 2490C IJX020450A 2490C IJX020467A 2490C IJX020566A 2490C IJX020620A 2490C IJX020715A 2490C IJX020774A 2490C IJX020781A 2490C IJX020803A 2490C IJX020806A 2490C IJX020811A 2490C IJX020846A 2490C IJX020861A 2490C IJX020862A 2490C…
Reason for recall
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
FDA-determined cause: Software design (manufacturing process)
Action taken
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.
Details
- Recall number
- Z-1605-2016
- Initiated
- March 31, 2016
- Terminated
- September 25, 2017
- Product code
- NVZ – Pulse Generator, Permanent, Implantable
- Quantity
- 5038
- Distribution
- AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN.
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure, Mounds View, MN