ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
FDA Recall Z-1041-2007 · Posted 2007-07-03
Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJQP
Date Initiated2007-05-15
Date Terminated2007-11-27
Product Quantity1 unit.
Reason for Recall
Product's hinged lid can fall, if not fully opened as designed, representing a potential injury hazard to the operator.
Firm Action
Firm notified consignee via letter on 05/15/07. Consignee informed of potential for injury and advised that a label would be affixed to the device lid by an Abbott representative.
Root Cause
Other
Distribution Pattern
Device distributed to a hospital in UT.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.