Recall Z-1041-2007 ยท JQP Calculator/Data Processing Module, For Clinical Use
Abbott Laboratories, Inc
ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
| Date | Jul 3, 2007 (initiated May 15, 2007) |
| Status | Terminated |
| Reason | Product's hinged lid can fall, if not fully opened as designed, representing a potential injury hazard to the operator. |
| 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 | 1 unit. |
| Distribution | Device distributed to a hospital in UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.