FDA Device

Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081

Hazard

Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.

What You Should Do

Remedy

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.

Products

Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081
Brand
Medtronic Gastroenterology Urology
UPC
All serial numbers

Units Affected

42 units