AccuChek Spirit insulin infusion pump.
FDA Recall Z-1734-2015 · Posted 2015-06-09
Recalling FirmRoche Diabetes Care, Inc.
Recall StatusTerminated
Product CodeLZG
Date Initiated2015-04-22
Date Terminated2016-11-03
Product Quantity35,795
Reason for Recall
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
Firm Action
Roche sent an URGENT MEDICAL DEVICE CORRECTION notification dated April 22, 2015, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer.
The recall notification included a description of the reason for the recall, customer responsibilities, training chart, and instructions for responding to the formal recall notification. Please contact the ACCU-CHEK Customer Care Service Center, 24 hours a day, seven days a week at 1-800-688-4578, if you have questions about the information contained in this notification.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.