GE Healthcare, Discovery IGS 740
Medical device recall Z-1707-2016. Published in FDA’s Enforcement Report on Jun 1, 2016.
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 Jun 1, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 25 states named
- 25 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?
Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
25, 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 Mfg Lot or Serial # System ID 664365BU4 804828CATH4 669085BU3 573815D730 668484BU9 714FVDISC 672437BU1 775770CATHLAB3 0000HXF3001331 801714DIS730 00000632172BU3 203694IGS730 00000633128BU4 309624FT6…
Every code shown here, 1,453 characters
Mfg Lot or Serial # System ID Mfg Lot or Serial # System ID 664365BU4 804828CATH4 669085BU3 573815D730 668484BU9 714FVDISC 672437BU1 775770CATHLAB3 0000HXF3001331 801714DIS730 00000632172BU3 203694IGS730 00000633128BU4 309624FT6 00000633831BU3 619532DISCOVERY 00000630288BU9 303426IR 0000HXF3001333 949250DISC730 00000637023BU3 214345IGS730 0000HXE9001300 650723SC1 00000646169BU3 330375HOR 00000638611BU4 414649DIS1 00000646917BU5 720854IGS730 00000614688BU0 610954OR1 00000622054BU5 423778DISC 646007BU5 206VMDISCOVERY1 00000637724BU6 281BAYIGS730 Not Avaialble GON4345699 Not Avaialble GON4110095 Not Avaialble DZ1104VA03 00000661681BU7 030078RX05 00000651337BU8 190059RX30 00000659126BU7 210060RX14 0000HXE9001292 613722D730 00000650197BU7 082416040061 00000653093BU5 082416040069 00000668482BU3 082416040074 Not Avaialble 082416060019 00000653092BU7 082416100080 00000651999BU5 082416120043 Not Avaialble 082416200019 00000618688BU6 M54866AG1 00000614687BU2 A4185526 0000013A2A0001 M40480222 00000623224BU3 M4160476 00000663234BU3 M94838145 00000646918BU3 S41600101 00000650095BU3 HC4348XR11 00000671395BU2 HC4348XR14 00000660146BU2 HU1205VA03 00000627794BU1 IE1147VA01 00000672728BU3 B5120737 00000642198BU6 YV2000 BAPFI0033-0011 XV649425BU6 00000653091BU9 XVE14287001 Not Avaialble SA2454VA01 00000615500BU6 0847160010 0000014A2A0010 AE1477VA01 Not Avaialble GON4316421 00000642197BU8 10692VAS01 00000638812BU8 00169VAS01 Not Avaialble 00584VAS06
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) including the states of AL, CA, CO, CT, IL, IN, MD, MN, MS, MO, NE,NV,NH, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of ALGERIA, BELGIUM CANADA, CHINA, FRANCE, GERMANY, HUNGARY, IRELAND, ITALY, JAPAN, MEXICO, NETHERLANDS, PERU, SAUDI ARABIA, SINGAPORE, UNITED ARAB EMIRATES, and UNITED KINGDOM.
The states and territories these words name
25 states and territories.
Every one of them
- Alabama
- California
- Colorado
- Connecticut
- Illinois
- Indiana
- Maryland
- Minnesota
- Missouri
- Mississippi
- Nebraska
- New Hampshire
- New Mexico
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
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 Apr 15, 2016.
- FDA classified it on May 23, 2016.
- FDA’s Enforcement Report published it on Jun 1, 2016.
- FDA terminated it on Nov 22, 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.”
- 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
-
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.