Z-0453-2015Class II

Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography...

Name: Z-0453-2015 Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography...
Creator: GE Healthcare, LLC
Published: 2014-09-04
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-09-04 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and... on 2014-09-04. FDA classified it as Class II and gives the reason as "Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0453-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-04
Posted: 2014-12-16
Terminated: 2015-01-21
Recalling firm: GE Healthcare
Product: Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were sent on 9/4/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12218 dated September 4, 2014. The letter was addressed to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. Customers are to perform a system functional check as instructed in the letter. If the check fails, they should contact their local GE Healthcare Service Representative. GE Healthcare will correct all systems at no cost to the customer, and a representative will contact customers to arrange for the correction. For questions they can call US 800-437-1171. For other countries they can call their local GE Healthcare Service Representative.
Quantity in commerce: 6 (1 US, 5 OUS)
Distribution: Worldwide Distribution -- US, including the states of CA, CO, FL, MO, PA; and, the countries of BELGIUM, CHINA, COLOMBIA, FRANCE, GREECE, MEXICO, and RUSSIA.
Product codes and lots: Mfg Lot or Serial # System ID 00000583668BU9 610983INNOVA3 00000643314BU8 082406090024 00000644609BU0 082406210011 00000645290BU8 082406110006 00000645780BU8 082406040032 00000648200BU4 082406070014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0453-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0451-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-12
Z-0452-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-12
Z-0453-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-12

Product code OWB

K052412Class IIInnova 2100-Iq, Innova 3100, Innova 3100-Iq, Innova 4100, and Innova 4100-IqGE Healthcare / cleared 2005-09-16

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)