GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye…
Medical device recall Z-0184-2015. Published in FDA’s Enforcement Report on Nov 19, 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 Nov 19, 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 3 states named
- 2479 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 is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H3000YG, H3000YM, H3000YS, H2400YJ, H2400YK. Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
2479, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
15012 919684INF1 16089 319356INF 16168 801562JVH02 16074 519749INFINIA2 16061 82426040033 16076 82426040030 16085 82426310015 16158 DK1029NM05 16067 FI1023MN02 16068 FI1153MN01 16141 A5152964 16056 NO1088MN09 16152 00053NUC06 16001…
Every code shown here, 1,986 characters
15012 919684INF1 16089 319356INF 16168 801562JVH02 16074 519749INFINIA2 16061 82426040033 16076 82426040030 16085 82426310015 16158 DK1029NM05 16067 FI1023MN02 16068 FI1153MN01 16141 A5152964 16056 NO1088MN09 16152 00053NUC06 16001 906776INF 16005 615768SCNM1 16015 717782INF 16018 907562NM1 16033 318681INFINIA 16036 920738INF 16043 210921NM1 16045 941637INF 16051 507345INF1 16054 630801INF 16065 860350INIF 16071 763UNTYINFI 16075 937328INF2 16083 973625INFINIA 16084 518828INF 16088 908522INFINIA 16098 203325INF2 16111 956350NM1 16118 814533INF 16123 716366INF 16162 704783INFI3 16166 717627INFINIA 16436 203325INF 16140 110034NU04 16022 905372INFINIA 16039 905731INFINIA 16044 519749INFINIA 16072 450654INF2 16016 M2269829 16092 V2728105 16114 S4160059 16079 783348NU01 16017 HU1039NM02 16126 83026602101643 16135 A5172907 16142 A5197927 16115 850260061 16130 850260060 16170 850260063 18130 2919654INF 16019 MA1154NM02 16106 O005NU14 16049 45001NUC01 16004 00216NUC11 1505 508427INFINIA 10548 608263INF 15010 727461VG 15013 661633NM1 16006 310543INF1 16007 619482INFINIA 16008 509474INFINIA 16009 434924INF2 16010 605333INFINIA 16013 303320IH 16020 775423INF1 16021 928537INF 16026 941629INF 16028 434924INF1 16029 408259IN1 16030 626570INF1 16035 907562NM2 16037 713785SLINF1 16038 LGMCINF2 16046 757668INF1 16050 989723INF1 16052 206223INF 16055 215952INF 16059 916983INFN1 16062 937328INF1 16069 715839INF 16070 225765INF1 16073 989723INF2 16082 516570INF 16109 920684INF 16110 408559IN1 16112 801584INF1 16121 801584INF2 16124 704384HAWK1 16151 603650INFINIA1 16159 937208INF1 16163 615322NM3 16169 858554INF1 16171 409727NM1 16173 508828INF 16097 910266042 16122 910266045 16133 910263135 15006 130139NU02 16040 030209NU02 16128 110022NU03 16027 519752INFINIA 16060 450654INF1 16153 604278INFINIA1 16154 604875INFINIA2H 16138 82426090016 16172 82426160026 16174 82426310025 16024 82426200003 16014 C4191749 16023 M2846905 16101 V8572204 16146 828260005 16066 83026805120043…
FDA’s list runs to 41,733 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) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.
The states and territories these words name
- District of Columbia
- Guam
- Puerto Rico
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 Oct 14, 2014.
- FDA classified it on Nov 7, 2014.
- FDA’s Enforcement Report published it on Nov 19, 2014.
- FDA terminated it on Feb 27, 2015.
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 41,733 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.