Medtronic SynchroMed recall: Software Issue
Medtronic SynchroMed, Model A10
Why was Medtronic SynchroMed recalled?
The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 00643169771031, All serial numbers with software version 1.1.300.
- Product
- Medtronic SynchroMed, Model A10
- Recalling firm
- Medtronic Inc.
- Quantity
- 2543 units
- Distribution
- Foreign Distribution
- Recall date
- December 20, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)