Medtronic SmartSync software update removes an erroneous electrical reset message
Medtronic SmartLink Software on the SmartSync Patient Connector is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 3,909 units affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for a false-positive on-screen message where no device reset actually occurred, with no patient consequence stated in the source.
Plain-English summary
Medtronic SmartLink Software loaded on the SmartSync Patient Connector, model number 24967, is being recalled across its software components, including the Azure Astra application (software model D00U003) and the Percepta Serena Solara application. The action covers 3,909 units.
According to the manufacturer, a software update for Medtronic CareLink SmartSync Device Manager is now available which eliminates the potential display of an erroneous electrical reset pop-up message upon interrogation with a SmartSync Device Manager. The erroneous message indicates that an electrical reset has occurred when no reset has taken place. The FDA classified the action as Class II.
Distribution was worldwide. The software is used by healthcare facilities rather than sold to consumers.
Facilities should identify affected installations using the software model numbers and GTINs in the recall notice and follow the instructions issued by Medtronic.
The recalled product
- Product
- Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt…
- Manufacturer
- Medtronic, Inc.
- Affected units
- 3,909
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Software Model Number
- D00U003
- GTIN 00763000002039
- Updated Software Version 6.5.5
- 2. Software Model Number
- D00U004
- GTIN 00763000002046
- 3. Software Model Number
- D00U005
- GTIN 00763000002053
- Updated Software Version 9.5.2
- 4. Software Model Number
- D00U006
- GTIN 00763000397852
- Updated Software Version 4.4.6
- 5. Software Model Number
- D00U007
- GTIN 00763000397869
- 6. Software Model Number
- D00U008
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Medtronic, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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