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Terminated

GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System

FDA Recall Z-1155-2009 · Posted 2009-09-24

Recalling FirmGe Healthcare
Recall StatusTerminated
Product CodeJAA
Date Initiated2009-02-19
Date Terminated2011-07-22
Product Quantity554 units

Reason for Recall

The alarm timer is reset after each exposure and therefore never reaches the five minute alarm state unless one exposure exceeds 5 minutes in duration.

Firm Action

GE Healthcare sent a customer notification out to all sites that have potentially affected systems. GEHC Surgery will also install a software correction into the affected systems in order to resolve this issue at no charge to the customer. Until the GEHC OEC Fluorostar 7900 has received the corrective software installed, they are encouraging facilities to exercise caution in monitoring the amount of cumulative fluoroscopy time when the affected system is in use.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043076GE OEC FLUOROSTARGe Oec Medical Systems, Inc. · 2004-12-22

Official Source

View FDA Recall →

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

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