Z-0114-2013Class II

GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating...

Name: Z-0114-2013 GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating...
Creator: GE Healthcare, LLC
Published: 2011-12-20
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-12-20 / Terminated

FDA source

GE Healthcare, LLC began a recall of GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular... on 2011-12-20. FDA classified it as Class II and gives the reason as "It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0114-2013
Classification: Class II
Status: Terminated
Initiated: 2011-12-20
Posted: 2012-10-17
Terminated: 2013-09-18
Recalling firm: GE Healthcare
Product: GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. A GE Healthcare Service Representative will replace the collimator to address the issue. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. Further questions please call 262-513-4122.
Quantity in commerce: 199 installed in the US
Distribution: Nationwide distribution
Product codes and lots: Model number - 5892935G052G

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0114-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0113-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-22
Z-0114-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-22
Z-0115-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-22

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)