Recall Z-0522-2024— Medtronic Inc.
Class II · Completed
Class II FDA medical device recall by Medtronic Inc., initiated 2020-07-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic SynchroMed, Model A10. Reason: 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..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2020-07-13
- Firm location
- Mounds View, MN, United States
Product description
Medtronic SynchroMed, Model A10
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.