Company: GVI Technology Partner
Date of Enforcement Report: 2/18/04
Class: III
PRODUCT
CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version BIA. Recall # Z-0527-04.
REASON
Due to limitations in the operating software, the acquired scan may not be processed properly.
CODE
S/Ns: 100 thru 105, and 107 thru 116.
RECALLING FIRM/MANUFACTURER
GVI Technology Partners, Twinsburg, OH, by letter on January 16, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
PA, OH, FL, and SC.
