Z-1985-2015Class II

GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational...

Name: Z-1985-2015 GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational...
Creator: GE Healthcare
Published: 2015-05-29
License: https://open.fda.gov/license/

GE Healthcare / initiated 2015-05-29 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare began a recall of GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional... on 2015-05-29. FDA classified it as Class II and gives the reason as "GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery)". 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-1985-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Posted: 2015-07-03
Terminated: 2015-10-28
Recalling firm: GE Healthcare
Product: GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 7
Distribution: Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.
Product codes and lots: Serial Number System ID Not Available GON4271838 Not Available 229890CL Not Available 361788CL323 Not Available 806358INNOVA 0C2V069A4104R1 082416310033 0C2V069A4202R1 082416200021 0C2V069A4203R1 082416050013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1985-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1973-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1974-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1975-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1976-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1977-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1978-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1979-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1980-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1981-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1982-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1983-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1984-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1985-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02

Product code IZI

K122457Class IIGe Innova/innova Igs/discovery Igs/optima Angiographic, Fluoscopic X-Ray Systems with Cathlab Frontiers SolutionsGE Healthcare / cleared 2013-01-02

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)