Recall Z-0924-04 ยท FFX System, Gastrointestinal Motility (Electrical)
Medtronic Gastroenterology / Urology
Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081
| Date | Jul 20, 2004 (initiated Apr 28, 2004) |
| Status | Terminated |
| Reason | Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short. |
| Root cause | Other |
| Action | Letters dated April 28, 2004 were sent to the consignees. Enclosed with the letter to each consignee were replacement power cord(s). The letters instruct consignees to replace the current power cord by following instructions enclosed with the letter. |
| Quantity | 42 units |
| Distribution | The devices were distributed nationwide in the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981733 | DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 Medtronic Functional Diagnostics A/S, Feb 4, 1999 |