Z-0133-2012

GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicated for use in...

Name: Z-0133-2012 GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicated for use in...
Creator: GE Healthcare, LLC
Published: 2011-08-24
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-08-24 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicated for use in generating fluoroscopic images of human anatomy for... on 2011-08-24. The reason FDA records is "A potential weakness on the monitor suspension end-stop device may impact user safety. The end-stops may break if the monitor-suspension is repeatedly pushed with excessive force on the end rails". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0133-2012
Status: Terminated
Initiated: 2011-08-24
Posted: 2011-10-28
Terminated: 2012-05-29
Recalling firm: GE Healthcare
Product: GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging-procedures.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: A potential weakness on the monitor suspension end-stop device may impact user safety. The end-stops may break if the monitor-suspension is repeatedly pushed with excessive force on the end rails.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A GE Healthcare "Urgent Medical Device Correction" letter dated August 22, 2011 was sent out 8/24/11. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology & Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Users were told to operate the suspension without excessive force. If one of the end-stops breaks, then the system should not be used and their local GE Healthcare Service Representative should be contacted. GE will contact customers to replace all end-stops at no cost to the customer. Questions or concerns should be directed to 800-437-1171 in the US and 0120-055-919 in Japan. For other countries, customers can contact their local GE Healthcare Service Representative.
Quantity in commerce: 15
Distribution: Worldwide Distribution -- USA, including the states of TX & NC and the countries of TURKEY, POLAND, MEXICO, CHINA, CAMBODIA, BRAZIL, BOLIVIA, and SAUDI ARABIA.
Product codes and lots: 00000002010011 599032BU0 00000002011001 00000002011002 598347BU3 00000002010013 00000002010017 00000002010012 00000002010014 00000002010015 599038BU7 00000002010016 00000002010010 00000002011003 00000002010007

Product code MQB

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)