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Terminated

GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc.

FDA Recall Z-1302-06 · Posted 2006-09-30

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2006-08-16
Date Terminated2011-07-27
Product Quantity8,266 units (US), 2,664 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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024012OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems · 2003-03-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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