OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
FDA Recall Z-1865-2012 · Posted 2012-06-22
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Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2006-11-20
Date Terminated2012-06-25
Product Quantity717 units
Reason for Recall
Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot mode", and the system does not reboot.
Firm Action
On 11/20/06 two written notifications were sent to consignees addressed to the Facility Administrator and the Radiology Administrator. The notifications advised them that GE Healthcare had identified several intermittent potential safety issues that may occur with the product. Interim solutions were provided for each issue. The letter stated that GEHC OEC would contact customers and remedy the issues free of charge when a permanent solution became available. An Urgent Recall Notice, dated April 13, 2007, was also sent to customers. Customers were to contact the service team at 800-874-7378 for further information, if there were any questions or concerns.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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