Innova IGS 540 recallZ-0451-2015 · GE Healthcare, LLC · initiated Sep 4, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0451-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 4, 2014
- Posted by the FDA
- Dec 16, 2014
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 10 (4 US, 6 OUS).
- Product code
- IZI
- FDA submissions
- K122457
- 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 description
Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Code information (models, lots, serial numbers)
Mfg Lot or Serial # System ID 00000642076BU4 303695IR1 00000642193BU7 0004040462 00000646910BU0 314768SM10 00000647792BU1 904UFHNSP 00000646492BU9 XV386041GE8 00000646048BU9 S4160099 00000644611BU6 H2009VAS44 00000646493BU7 H0008VAS06 00000645027BU4 XV106184CX5 00000646491BU1 4184240
Other devices under the same FDA submission
1 device cleared under K122457 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- INNOVA IGS 5 001Ge Medical Systems · System, x-ray, fluoroscopic, image-intensified1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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