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Terminated

GE OEC 8800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah

FDA Recall Z-0850-2007 · Posted 2007-06-30

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-06-12
Date Terminated2011-11-01
Product Quantity22 units

Reason for Recall

X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

Firm Action

Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems.

Root Cause

Other

Distribution Pattern

Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Switzerland, Taiwan, and the UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003837FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems · 2001-03-12

Official Source

View FDA Recall →

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

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