Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1041-2007

ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate...

Abbott Medical / initiated 2007-05-15 / Terminated

Abbott Laboratories, Inc began a recall of ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy on . The reason FDA records is "Product's hinged lid can fall, if not fully opened as designed, representing a potential injury hazard to the operator". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1041-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Abbott Medical
Product
ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall
Product's hinged lid can fall, if not fully opened as designed, representing a potential injury hazard to the operator.
FDA root cause
Other
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.
Quantity in commerce
1 unit.
Distribution
Device distributed to a hospital in UT.
Product codes and lots
LN 7L01-01.