GE Healthcare Innova X-ray Imaging Systems…

Date posted by the FDA

March 19, 2012

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications.

Reason

It was discovered that when the Diamentor M4-KDK is installed on an Innova system the dose display is disabled on the certified Innova monitor and enabled on the Diamentor M4-KDK which is not certified as required by FDA regulation (Subpart J).

Distribution pattern

USA Nationwide Distribution

Quantity

19

Codes and lots

Innova 2100, 3100, 4100, 2121, and 3131

Recall started

May 4, 2011

Device type

System, X-Ray, Angiographic

Root cause (FDA)

Radiation Control for Health and Safety Act

What the company told customers

GE Healthcare will alert affected Innova users with a Diamentor M4-KDK unit of this issue and the workaround to mitigate this issue. GE Healthcare will bring affected Innova units in the field into compliance by enabling the Innova certified display and providing affected customers with an Operators Manual Addendum and Service Manual Addendum which will address this topic. GE Healthcare will correct all affected systems by updating the system's Operator and Service Correction manuals and enabling the innova dose display on the Live and Reference monitors and the DLconsole. The Diamentor M4-KDK can still be used to display additional informative dose values. GE Healthcare will, without charge, remedy the defect or bring the product into compliance; the details of which will be included in a subsequent communication to you or through a GE field engineer site visit. GE Healthcare updated the Innova User Instructions, as part of the recall, to indicate to meet regulatory requirements based on the international safety standards IEC 60601-2-43:2000 and/or 21 CFR 1020.30 (k), use as reference the exposure dose displayed on the DL console, live or reference monitor. If you have any further questions or concerns please call 800-437-1171.

Recall number

Z-1124-2012

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1124-2012. The agency record governs; check it and the company before acting.