Medtronic SynchroMed, Model A10
FDA device recall Z-0522-2024 · posted 2023-12-09 · Completed
Recall details
- Recalling firm
- Medtronic Inc.
- 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.
- Action taken
- Medtronic issued a SAFETY NOTIFICATION to its consignees on 07/13/2020 by letter. The notice explained the problem with the device and requested the software be upgraded to version 1.1.342.
- Root cause
- Software Design Change
- Status
- Completed
- Product code
- LKK
- Quantity affected
- 2543 units
- Distribution
- Foreign Distribution
- Date initiated
- 2020-07-13
- Date posted
- 2023-12-09
- Location
- Mounds View, MN
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