Known Identifiers & Locations
FEI Numbers
3003166194
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0010-05 |
Medtronic MiniMed Paradigm Model 712
Reason: Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.
|
2004-09-14 |
Terminated
|
View Details
|
| Z-0011-05 |
Medtronic MiniMed Paradigm Model 512
Reason: Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.
|
2004-09-14 |
Terminated
|
View Details
|
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