RUS Tool Version Software
FDA Recall Z-1303-06 · Posted 2006-09-30
Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2006-08-16
Date Terminated2011-07-27
Product Quantity121 units (US), 0 units (foreign)
Reason for Recall
X-ray systems could provide output which exceeds the 20 R/minute limit.
Firm Action
Consignees were notified by certified letter on 08/14-15/2006.
Root Cause
Other
Distribution Pattern
Worldwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.