Company: Adac Labs
Date of Enforcement Report: 7/21/04
Class: III
PRODUCT
Emission Computed Tomography System. Recall # Z-1079-04.
REASON
Software problems may cause the detector head to drift unexpectedly.
CODE
Model number 2163-3000A, 2163-3000B; 510K K011611.
RECALLING FIRM/MANUFACTURER
Adac Labs, Milpitas, CA, by letter on June 21, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
483 units.
DISTRIBUTION
Nationwide.