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Terminated

GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.

FDA Recall Z-2221-2012 · Posted 2012-08-17

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-10-19
Date Terminated2012-08-17
Product Quantity175 units

Reason for Recall

X-ray units did not meet manufacturer's specification for linearity.

Firm Action

GE updated their user manual and changed their internal specifications to match those of the CFR In addition, a software code correction was to be made to forward productions in order to correct the reported defect. *** This recall issued was previously classified under an incorrect recall number. It is being reclassified with a new number. ***

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - USA - Australia, Brazil, Cameroon, China, Colombia, Cyprus, The Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Malaysia, The Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Taiwan, Turkey, UAE, UK, and Canada.

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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