GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients…
Medical device recall Z-0413-2016. Published in FDA’s Enforcement Report on Dec 23, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 23, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 19 states named
- 108 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems .
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are 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. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
108, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # System ID 00000085795HL3 812265CL1 00000086408HL2 313343IN1 00000087377HL8 361888CRC 00000089316HL4 201541LAB1 00000091432HL5 615396CV1 00000092611HL3 910671CL323A 00000095315HL8 910671CL323B 00000096904HL8 337494CATH1…
Every code shown here, 1,992 characters
Mfg Lot or Serial # System ID 00000085795HL3 812265CL1 00000086408HL2 313343IN1 00000087377HL8 361888CRC 00000089316HL4 201541LAB1 00000091432HL5 615396CV1 00000092611HL3 910671CL323A 00000095315HL8 910671CL323B 00000096904HL8 337494CATH1 00000097546HL6 631654INNOVA 00000097777HL7 937592OPT 00000098434HL4 504568INNOVA41 00000098435HL1 702616RDL31 00000098828HL7 843339INNOVA2 00000098977HL2 202269INNOVA 00000099837HL7 520417OPT3100 00000101009HL9 308865KR31 00000101825HL8 216778LABC 00000112807HL3 517353CATH 00000115275HL0 407CCE323 00000116573HL7 509837SSCL1 00000117808HL6 GON4173729 00000118032HL2 812284IN31 00000118368HL0 318330INNOVA1 00000118712HL9 361788CL323 00000118714HL5 806358INNOVA 00000119286HL3 912384CL 00000119585HL8 GON4263188 00000120996HL4 GON4263188 00000121694HL4 229890CL 00000121719HL9 520GVHCATH 00000124905HL1 217443PUSAM323 00000124965HL5 941483CL1 00000126533HL9 702880CATH1 00000127011HL5 318704CATH2 00000110028HL8 DZ1605VA01 00000108050HL6 082416090051 00000112754HL7 082416230024 00000113435HL2 GON4217188 00000113700HL9 082416010027 00000113963HL3 082416090050 00000113977HL3 082416090047 00000116179HL3 082416090058 00000116903HL6 082416100086 00000117226HL1 082416090053 00000117334HL3 082416120042 00000117414HL3 GON4229674 00000117572HL8 GON4242594 00000119287HL1 082416090062 00000119871HL2 082416210033 00000120419HL7 082416190023 00000120578HL0 082416190021 00000120736HL4 082416090059 00000120847HL9 082416090064 00000120867HL7 082416100085 00000120982HL4 082416060016 00000121662HL1 082416090067 00000122668HL7 082416140017 00000122850HL1 082416250010 00000123076HL2 082416180016 00000123319HL6 082416310033 00000123501HL9 082416050013 00000123712HL2 082416200021 00000124692HL5 082416190022 00000125706HL2 082416100095 00000125713HL8 082416190024 00000125813HL6 082416030027 00000125876HL3 082416030028 00000125896HL1 082416110023 00000126170HL0 082416070041 00000126248HL4 082416010028 00000126340HL9 082416200020 00000126419HL1 082416100096…
FDA’s list runs to 2,955 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide in the states of: AR, AZ, DC, FL, GA, IL, IN, LA, MI, NC, NE, NJ, NV, NY, OH, SC, TN, TX, WA. and the countries of Algeria, Bangladesh, Bosnia and Herzegovina, Brazil, China, Dominican Republic, Ethiopia, Georgia, Germany, India, Indonesia, Italy, Lebanon Martinique , Morocco, Poland, Republic of Moldova, Russia, Spain Thailand, Trinidad, Turkey, and Uzbekistan.
The states and territories these words name
19 states and territories.
Every one of them
- Arkansas
- Arizona
- District of Columbia
- Florida
- Georgia
- Illinois
- Indiana
- Louisiana
- Michigan
- North Carolina
- Nebraska
- New Jersey
- Nevada
- New York
- Ohio
- South Carolina
- Tennessee
- Texas
- Washington
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 13, 2015.
- FDA classified it on Dec 12, 2015.
- FDA’s Enforcement Report published it on Dec 23, 2015.
- FDA terminated it on Sep 7, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,955 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.