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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67464

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 07, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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.

Z-1198-2014
Recall number
Z-1198-2014
Initiated
February 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
3062 units (1182 US, 1880 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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, 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00000000018-24, 00000000018-39, 00000000018-40, 00000000018-42, 00000000018BH2, 00000000019-34, 00000000021BH6, 00000000026BH5, 00000000027BH3, 00000000030-04, 00000000030-11, 00000000030-14, 00000000030-15, 00000000030-16, 00000000030BH7, 00000000031-11, 00000000032-10, 00000000032-13, 00000000033BH1, 00000000034-11, 00000000036BH4, 00000000041BH4, 00000000043-82, 00000000044-10, 00000000044BH8, 00000000045BH5, 00000000050-08, 00000000050BH5, 00000000053BH9, 00000000054-04, 00000000056BH2, 00000000059BH6, 00000000062BH0, 00000000065BH3, 00000000068BH7, 00000000069BH5, 00000000077BH8, 00000000078BH6, 00000000086BH9, 00000000091BH9, 0000000010-134, 0000000010-191, 0000000010-203, 00000000109BH9, 00000004-4-604, 000000099-4-04, 00000011278NU9, 000000163-1758, 00000054895HL8, 00000054915HL4, 00000055050HL9, 00000056555HL6, 00000061940HL3, 00000087649BT0, 00000163-15-28, 000003100-1716, 000003100-1719, 000003100-1740, 000003100-1743, 000003100-1744, 000003100-1760, 000003100-1763, 000003100-1829, 000003100-1838, 000003100-1840, 000003101-1502, 000003651-4185, 000003681-1803, 000003818-1210, 000003818-1224, 000003818-4187, 000008125-1630, 00000I92S08001, 00000ICPO50612, 00003618-12-26, 00003652-41-95, 00003817-11-12, 00003817-11-69, 00003818-11-41, 00003818-11-47, 00003818-11-82, 00003818-12-19, 00003818-32-02, 00008125-16-25, 00008125-16-70, 00008125-16-88, 00008125-16-89, 00008125-18-09, 00008125-18-10, 00008125-18-16, 00008125-18-18, 0000D4360X4372, 0003811-81-231, DUMFMI40849005, DUMFMI40849009, DUMFMI40849010, DUMFMI40849011, DUMFMI40849012, DUMFMI40849013, DUMFMI40849014, DUMFMI40849015, DUMFMI40849016, DUMFMI40849017, DUMFMI40849018, DUMFMI40849019, DUMFMI40849020, DUMFMI40849023, DUMFMI40849026, UNKASM00109200, UNKASM00109201, UNKASM00109204, UNKELS00000372.

Distribution pattern

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.

device · product 2 of 3

GE Healthcare Varicam/VG and VG Hawkeye 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 typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.

Z-1199-2014
Recall number
Z-1199-2014
Initiated
February 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
3062 units (1182 US, 1880 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

all serial numbers are listed in Product 1

Distribution pattern

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.

device · product 3 of 3

Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera 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 typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.

Z-1200-2014
Recall number
Z-1200-2014
Initiated
February 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
3062 units (1182 US, 1880 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

all serial numbers are listed in Product 1.

Distribution pattern

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.