GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems
Medical device recall Z-1198-2014. Published in FDA’s Enforcement Report on Mar 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 Mar 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 2 states named
- 3062 units (1182 US, 1880 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?
Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. N
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. 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.
3062 units (1182 US, 1880 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers for all devices: 22, 343, 1002, 1003, 1006, 1007, 1008, 1010, 1012, 1013, 1016, 1018, 1019, 1021, 1025, 1026, 1027, 1034, 1035, 1038, 1039, 1042, 1043, 1046, 1056, 1058, 1060, 1061, 1065, 1066, 1069, 1072, 1073, 1074, 1075,…
Every code shown here, 1,996 characters
Serial Numbers for all devices: 22, 343, 1002, 1003, 1006, 1007, 1008, 1010, 1012, 1013, 1016, 1018, 1019, 1021, 1025, 1026, 1027, 1034, 1035, 1038, 1039, 1042, 1043, 1046, 1056, 1058, 1060, 1061, 1065, 1066, 1069, 1072, 1073, 1074, 1075, 1076, 1078, 1080, 1081, 1085, 1086, 1091, 1095, 1099, 1100, 1101, 1101, 1102, 1105, 1106, 1107, 1110, 1111, 1112, 1116, 1118, 1119, 1126, 1132, 1141, 1144, 1145, 1149, 1153, 1155, 1289, 1372, 1505, 1538, 1617, 1629, 1649, 1666, 1693, 1696, 1697, 1704, 1729, 1730, 1756, 1804, 1814, 1831, 1835, 1890, 1998, 1999, 3003, 5004, 5007, 8007, 10023, 10028, 10032, 10040, 10041, 10057, 10103, 10115, 10121, 10124, 10129, 10130, 10133, 10138, 10139, 10143, 10146, 10146, 10150, 10156, 10158, 10164, 10165, 10166, 10167, 10168, 10169, 10171, 10172, 10173, 10175, 10176, 10177, 10178, 10179, 10180, 10180, 10182, 10185, 10187, 10188, 10189, 10190, 10191, 10193, 10194, 10195, 10197, 10199, 10204, 10206, 10207, 10209, 10210, 10211, 10212, 10216, 10217, 10218, 10222, 10224, 10225, 10228, 10229, 10230, 10234, 10235, 10236, 10237, 10238, 10239, 10240, 10241, 10242, 10243, 10244, 10246, 10249, 10250, 10251, 10253, 10254, 10256, 10260, 10262, 10263, 10264, 10265, 10267, 10268, 10269, 10270, 10272, 10276, 10279, 10280, 10281, 10282, 10283, 10284, 10287, 10288, 10292, 10294, 10295, 10297, 10298, 10300, 10302, 10303, 10305, 10307, 10308, 10309, 10311, 10312, 10313, 10314, 10316, 10319, 10320, 10323, 10325, 10326, 10328, 10332, 10333, 10334, 10335, 10336, 10336, 10337, 10338, 10339, 10340, 10342, 10343, 10345, 10346, 10347, 10348, 10352, 10353, 10354, 10355, 10357, 10359, 10360, 10362, 10363, 10364, 10366, 10367, 10368, 10370, 10371, 10373, 10374, 10375, 10376, 10377, 10378, 10379, 10381, 10382, 10383, 10384, 10385, 10386, 10387, 10388, 10389, 10390, 10392, 10393, 10395, 10396, 10397, 10398, 10399, 10400, 10401, 10401, 10402, 10403, 10405, 10406, 10407, 10408, 10409, 10410, 10411, 10412, 10413, 10414, 10416, 10417, 10420, 10422, 10424, 10425, 10426, 10428,…
FDA’s list runs to 22,792 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 Puerto Rico and Guam and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.
The states and territories these words name
- 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 Feb 7, 2014.
- FDA classified it on Mar 13, 2014.
- FDA’s Enforcement Report published it on Mar 19, 2014.
- FDA terminated it on Nov 3, 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 22,792 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.