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.
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