ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy
FDA device recall Z-1041-2007 · posted 2007-07-03 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Product's hinged lid can fall, if not fully opened as designed, representing a potential injury hazard to the operator.
- Action taken
- 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
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 1 unit.
- Distribution
- Device distributed to a hospital in UT.
- Date initiated
- 2007-05-15
- Date posted
- 2007-07-03
- Date terminated
- 2007-11-27
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.