Z-1124-2012

GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in...

Name: Z-1124-2012 GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in...
Creator: GE Healthcare, LLC
Published: 2011-05-04
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-05-04 / Terminated

FDA source

GE Healthcare, LLC began a recall of GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic... on 2011-05-04. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1124-2012
Status: Terminated
Initiated: 2011-05-04
Posted: 2012-03-19
Terminated: 2012-03-29
Recalling firm: GE Healthcare
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.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: 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).
FDA root cause: Radiation Control for Health and Safety Act
Action: 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.
Quantity in commerce: 19
Distribution: USA Nationwide Distribution
Product codes and lots: Innova 2100, 3100, 4100, 2121, and 3131

Product code IZI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)