Company:AGFA Corp.
Date of Enforcement Report 10/7/2009
Class:ll
PRODUCT
NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa’s Computed Radiography Systems with NX Workstations are intended for use in providing diagnostic quality images to aid the physician with diagnosis. Recall # Z-1889-2009
REASON
After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system..
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter on/about June 22, 2009.
Manufacturer: Agfa HealthCare GMBH, Peissenberg, Germany. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
97 units
DISTRIBUTION
IL, PA, TX, Canada, Europe, Asia Pacific and Latin America