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Discovery
Model NMCT 670 CZT · GE Medical Systems Israel, Functional Imaging · DI 00840682139380
JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750
KPS — System, Tomography, Computed, Emission · Class II · 21 CFR 892.1200
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (6)
Initiated
Recall #
Class
Status
Reason
Link basis
2022-12-19
Z-1057-2023
Class I
Open, Classified
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
k number procode
2020-12-10
Z-0855-2021
Class II
Open, Classified
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
k number procode
2020-08-14
Z-2993-2020
Class II
Terminated
Rotor bearing screws were found loose on
detector.
k number procode
2019-03-20
Z-1258-2019
Class II
Terminated
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
k number procode
2019-03-20
Z-1264-2019
Class II
Terminated
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
k number procode
2017-05-19
Z-2195-2017
Class II
Terminated
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
k number procode
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
5.1
2019-02
0
3.3
2019-03
0
3.15
2019-04
0
5.74
2019-05
0
3.31
2019-06
0
2.8
2019-07
0
2.58
2019-08
0
2.38
2019-09
0
2.14
2019-10
0
2.25
2019-11
0
1.86
2019-12
0
5.33
2020-01
0
1.92
2020-02
0
2.75
2020-03
0
2.17
2020-04
0
3.67
2020-05
0
2
2020-06
0
2.44
2020-07
0
2.25
2020-08
0
1.74
2020-09
0
1.95
2020-10
0
2.05
2020-11
0
2.24
2020-12
0
2.4
2021-01
0
1.47
2021-02
0
1.82
2021-03
0
2.43
2021-04
0
2.74
2021-05
0
3.77
2021-06
0
4.55
2021-07
0
3.07
2021-08
0
2.53
2021-09
0
2.3
2021-10
0
1.67
2021-11
0
2.62
2021-12
0
2.75
2022-01
0
1.89
2022-02
0
2.47
2022-03
0
2.43
2022-04
0
2.45
2022-05
0
1.73
2022-06
0
1.88
2022-07
0
3.53
2022-08
0
1.86
2022-09
0
2.81
2022-10
0
2.09
2022-11
0
2.07
2022-12
0
1.65
2023-01
0
2.31
2023-02
0
1.9
2023-03
0
2.63
2023-04
0
2.17
2023-05
0
2.57
2023-06
0
6.62
2023-07
0
2.1
2023-08
0
3.42
2023-09
0
2.95
2023-10
0
5.89
2023-11
0
2.58
2023-12
0
2.74
2024-01
0
1.9
2024-02
0
1.88
2024-03
0
1.85
2024-04
0
1.72
2024-05
0
2.24
2024-06
0
3.08
2024-07
0
1.88
2024-08
0
1.33
2024-09
0
1.17
2024-10
0
1.95
2024-11
0
1.45
2024-12
0
1.69
2025-01
0
1.59
2025-02
0
1.58
2025-03
0
1.39
2025-04
0
1.86
2025-05
0
2.5
2025-06
0
1.5
2025-07
0
1.5
2025-08
0
1.5
2025-09
0
1.67
2025-10
0
1.08
2025-11
0
1.28
2025-12
0
2.33
2026-01
0
2.22
2026-02
0
1.68
2026-03
0
1.45
2026-04
0
2
2026-05
0
2.19
2026-06
0
1.55
This device (reports/month)Average device in JAK, KPS (reports/device/month)
Regulatory clearances
K153402 SESE 2016-01-21 (k number procode)
Predicate lineage
K153402 — cites (transitively): K093514 (d1), K102231 (d1), K022960 (d2), K993813 (d2) — cited as predicate by K161740, K182484, K210173
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — GE Medical Systems Israel, Functional Imaging
NAI 2010-01-12 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · 0 citations