RecallDepth

Medtronic MiniMed Paradigm Model 512

Company
Medtronic Minimed
Recall Initiated
September 14, 2004
Terminated
March 3, 2005
Recall Number
Z-0011-05
Firm Location
Northridge, CA

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.

Distribution

Nationwide & Spain

Lot / Code Info

Paradigm model 512pumps with serial numbers that end in '-Axx4' . Where 'x' can be any number or letter.

Root Cause

Other

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