Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
FDA Recall Z-0106-04 · Posted 2003-11-13
Recalling FirmCti Pet Systems Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2003-10-02
Date Terminated2006-02-07
Product Quantity73
Reason for Recall
CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.
Firm Action
Written notification was sent out beginning 10/02/2003 to distributors and end users to advise them of the problem.
Root Cause
Other
Distribution Pattern
Nationwide International: Japan, Germany, Brazil, Spain, China, Russia, Austrailia, Hong Kong, Singapore, Poland France, Korea, Greece, UK and Austria
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.