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Terminated

GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC, Model 7700, GE Healthcare, Surgery, Salt Lake City, Utah

FDA Recall Z-0717-2008 · Posted 2008-03-15

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-09-28
Date Terminated2011-11-01
Product Quantity309 systems (Domestic), 101 (Foreign)

Reason for Recall

Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator.

Firm Action

On or about 9/6/2007, by Customer Notification Letter, users were notified that all affected units will be corrected by GE personnel with the addition of an additional shield.

Root Cause

Other

Distribution Pattern

Worldwide- USA including states of CO, DE, FL, NJ, MO, NY, PA, and TX (with VA and Military facilities) and countries of Australia, Austria, Belgium, Brazil, Chile, China, The Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Norway, Spain, Sweden, Switzerland, Thailand, and The UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000221SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARMGe Dec Medical Systems · 2000-04-11

Official Source

View FDA Recall →

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

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