GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ
Medical device recall Z-0021-2014. Published in FDA’s Enforcement Report on Oct 23, 2013.
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 Oct 23, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 2184 (1063 US. 1121 OUS) 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 become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
2184 (1063 US. 1121 OUS), 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 00000026767YY4 201982LCA 00000068001YY7 901384LCA 00000033988YY7 914737LCA 00000034024YY0 954LCA1 00000031679YY4 708216LLCA 00000952037WK0 630856LCN 00000320794BU1 082406010002 00000346260BU3 DR-27820-CO…
Every code shown here, 1,993 characters
Mfg Lot or Serial # System ID 00000026767YY4 201982LCA 00000068001YY7 901384LCA 00000033988YY7 914737LCA 00000034024YY0 954LCA1 00000031679YY4 708216LLCA 00000952037WK0 630856LCN 00000320794BU1 082406010002 00000346260BU3 DR-27820-CO 00000991021WK7 LB1160VA01 00000058879BU8 930047946 00000484712WK5 1453 00000529468WK1 915685LCA 00000528385WK8 082406040003 00000526149WK0 66324TC 00000497670WK0 M4017051 00000512202WK3 1616LCA 00000528587WK9 62134LCV+ 00000533252WK3 00001VAS01 00000548229WK4 506857LCA 00000088970BU9 0910063030 00000233847BU3 082406030001 00000238390BU9 083016598280384 00000245186BU2 RU1488RX20 00000249068BU8 34090VAS01 00000023887YY3 205599LCV 00000055095YY4 207283LC1 00000030139YY0 210428VCATH2 00000023954YY1 212604LC2 00000048123YY4 212604LCA2 00000048175YY4 214376VADV1 00000034312YY9 215576LC2 00000063851YY0 215662LCLP1 00000034351YY7 215955LCEP 00000034379448 216343LCA 00000026282YY4 216363LC 00000023914YY5 216384LCA 00000034355YY8 304256RCL1 00000055081YY4 304487LCA 00000048177YY0 305223LCV 00000023959YY0 305325LCA 00000063853YY6 307577HCL1 00000034352YY5 317818MDI111 00000055057YY4 317818MDI170 00000026283YY2 318462BCL 00000048183YY8 352333ANGIO 00000034327YY7 404991LCA 00000048150YY7 405271UC1 00000063859YY3 405359ELCV 00000023910YY3 407646CL1 00000034390YY5 409532GLCV 00000026316YY0 412578DLX 00000034341YY8 415540ADVLCLP 00000055053YY3 423493PSL 00000048145YY7 440585LCA 00000055092YY1 440835LCA 00000034383YY0 502587SP2 00000022054YY1 502933CL2 00000026276YY6 504380ADV1 00000048128YY3 540596LCV 00000034375YY6 561650LCA 00000030105YY1 601865ADY 00000030168YY9 615544LCA 00000034306YY1 615977SP 00000023934YY3 619340VA6 00000023871YY7 619347LC 00000030130YY9 619457SCL 00000026303YY8 619457SCL2 00000034347YY5 619739LC 00000055077YY2 661282CCLV 00000063864YY3 661326CATH1 00000030134YY1 704456LCV 00000034300YY4 707546ANGIO 00000030126YY7 717782LC1 00000034372YY3 717969LCC 00000030128YY3 718270LC 00000055052YY5 727521LCV 00000034376YY4 806358LCA…
FDA’s list runs to 56,412 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-USA (nationwide) including DC and Puerto Rico, and except ND, SD and VT, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY,GREECE, GUADELOUPE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN,IRELAND, ITALY, JAMAICA, JAPAN,JORDAN, KAZKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LIBYA ARAB JAMHIRIYA, LITHUANIA, MALAYSIA MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SLOVAKIA, SPAIN, SWEDEN, SYRIA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED KINGDOM, and VENEZUELA.
The states and territories these words name
- District of Columbia
- Puerto Rico
They leave out North Dakota, South Dakota and Vermont.
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 Aug 16, 2013.
- FDA classified it on Oct 17, 2013.
- FDA’s Enforcement Report published it on Oct 23, 2013.
- FDA terminated it on May 30, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, 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 56,412 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.