FDA Device

Emission Computed Tomography System

Hazard

Software problems may cause the detector head to drift unexpectedly

What You Should Do

Remedy

Notification letter sent to consignees 6/21/2004, software update pending (mandatory upgrade)

Products

Emission Computed Tomography System
Brand
Adac Labs
UPC
model number 2163-3000A, 2163-3000B

Units Affected

482 units