Recall record at a glance
| Official record | Z-1605-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Report date | May 11, 2016 |
| Recall initiation date | Mar 31, 2016 |
| Quantity | 5038 |
| Location | Mounds View, MN, United States |
Official product description
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.
Why the product was recalled
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
Distribution information
AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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