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Terminated

GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc.

FDA Recall Z-0041-2007 · Posted 2006-10-25

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2006-09-13
Date Terminated2009-08-13
Product Quantity40 units

Reason for Recall

Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy.

Firm Action

Consignees will be notified by letter beginning 10/16/2006.

Root Cause

Other

Distribution Pattern

FL, GA, IL, IN, LA, MA, MD, MO, NH, NJ, PA, TX, UT. Includes one VA facility in PA. China, France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041931OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATIONGe Oec Medical Systems, Inc. · 2004-08-26

Official Source

View FDA Recall →

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

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