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Terminated

OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc.

FDA Recall Z-0042-2007 · Posted 2006-10-14

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2006-09-30
Date Terminated2012-04-16
Product Quantity822 units

Reason for Recall

X-ray system may lose or mix images and/or lose patient data.

Firm Action

Consignees will be notified by letter beginning 10/21/2006.

Root Cause

Other

Distribution Pattern

Nationwide, including VA facilities in FL, NC, WA and military accounts in GA and WA. Foreign distribution to Australia, Belgium, Canada, Finland, France, Germany, Italy, Netherlands, New Zealand, Singapore, Spain, Sweden, Switzerland, UK.

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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