GE Healthcare
Medical device recall Z-1148-2014. Published in FDA’s Enforcement Report on Mar 12, 2014.
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 Mar 12, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 20 states named
- 283 (59 US, 224 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?
When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image, thus the line measurements may be inaccurate.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system
283 (59 US, 224 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 # 00000218194GE9 00000175340GE9 00000208598GE3 00000187433GE8 00000187429GE6 00000173818GE6 00000186994GE0 00000187437GE9 00000186992GE4 00000187432GE0 00000172803GE9 00000213684GE4 00000169498GE3 00000172802GE1…
Every code shown here, 2,000 characters
Mfg Lot or Serial # 00000218194GE9 00000175340GE9 00000208598GE3 00000187433GE8 00000187429GE6 00000173818GE6 00000186994GE0 00000187437GE9 00000186992GE4 00000187432GE0 00000172803GE9 00000213684GE4 00000169498GE3 00000172802GE1 00000171126GE6 00000213683GE6 00000171114GE2 00000171115GE9 00000171507GE7 00000171940GE0 00000171508GE5 00000171116GE7 00000171642GE2 00000171509GE3 00000171510GE1 00000171117GE5 00000175341GE7 00000180599GE3 00000218195GE6 00000212000GE4 00000207770GE9 00000171128GE2 00000175338GE3 00000194707GE6 00000180600GE9 00000207771GE7 00000171119GE1 00000180601GE7 00000171506GE9 00000172678GE5 00000171941GE8 00000171123GE3 00000171122GE5 00000171125GE8 00000186993GE2 00000171121GE7 00000171120GE9 00000186991GE6 00000186695GE7 00000171129GE0 00000207772GE5 00000211999GE8 00000194705GE0 00000175339GE1 00000171944GE2 00000198439GE2 00000187430GE4 00000183133HP8 00000171643GE0 00000L10106002 00000N10127001 00000V10334001 000000Z9309005 000000Z9309002 00000F10090001 00000H10153001 00000K10130001 000000G9337003 000000G9337002 00000W10230001 00000W10230002 00000H11083001 00000Y10245001 00000G10161002 00000M10162001 000000G9337001 00000180602GE5 00000187436GE1 00000171943GE4 00000194704GE3 00000194703GE5 00000194702GE7 00000175342GE5 00000187435GE3 00000172680GE1 00000171127GE4 00002UAO430KJL 00002UA04307KD 0000CZC9450FKS 0000CZC944B57J 0000CZC9385MCH 0000CZC94602P9 0000CZC94583RB 0000CZC1128HGN 0000CZC1128HGR 0000CZC1100YF8 0000CZC1128HGJ 00002UA04307L2 00002UA0430KL4 00002UA04307KV 00002UA04211JK 00002UA04307K5 0000CZC942647P 0000CZC9441VF1 00000V10245007 00000D10252002 0000CZC94602PY 0000CZC94602PC 00000185759HP8 0000CZC9406S71 0000CZC9412L3G 00000185734HP1 00000018579HP0 0000AB10235005 0000CZC9445HLZ 0000CZC9425PPQ 00000E10011004 00000E10011005 00000S11019009 00000S11019010 00000H11027003 00000Q11060006 000000G9337004 0000AB10126002 00000T10123004 00000E10336009 00000E10336005 00000E10336006 00000E10336008 00000E10011001 00000E10011002 00000T10123002…
FDA’s list runs to 4,264 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): AL, AZ, CA, CT, FL, IL, IN, IA, KY, MD, MA, MI, MS, NV, NH, NJ, NY, PA, WA, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KUWAIT, LATVIA, NEW ZEALAND, POLAND, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWEDEN,, SWITZERLAND, TAIWAN, and UNITED KINGDOM.
The states and territories these words name
20 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Connecticut
- Florida
- Iowa
- Illinois
- Indiana
- Kentucky
- Massachusetts
- Maryland
- Michigan
- Mississippi
- New Hampshire
- New Jersey
- Nevada
- New York
- Pennsylvania
- 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 Mar 25, 2011.
- FDA classified it on Mar 6, 2014.
- FDA’s Enforcement Report published it on Mar 12, 2014.
- FDA terminated it on Mar 13, 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: Visit.
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 4,264 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
-
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.