FDA-Device2015-06-17Class II
AccuChek Spirit insulin infusion pump.
Roche Diabetes Care, Inc.
Hazard
Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and El0 error messages. If the user does not act upon the E6 and E10 error messages appropriately, insulin delivery will be stopped and if unnoticed may lead to severe hyperglycemia u
Sold states
Nationwide Distribution
Affected count
35,795
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
AccuChek Spirit insulin infusion pump.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1734-2015Don't want to check this manually?
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