Medtronic MiniMed Paradigm Model 512
FDA Recall Z-0011-05 · Posted None
Recalling FirmMedtronic MiniMed
Recall StatusTerminated
Product CodeLZG
Date Initiated2004-09-14
Date Terminated2005-03-03
Reason for Recall
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.
Root Cause
Other
Distribution Pattern
Nationwide & Spain
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.