Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

AW

Model 4.7 · GE MEDICAL SYSTEMS · DI 00840682102278

LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050

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 (1)

InitiatedRecall #ClassStatusReasonLink basis
2013-09-19Z-0270-2014Class IITerminatedGE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correck 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.

61219252019-01: 0 reports for this device; peer average 5/device2019-02: 0 reports for this device; peer average 11.5/device2019-03: 0 reports for this device; peer average 8.71/device2019-04: 0 reports for this device; peer average 7.44/device2019-05: 0 reports for this device; peer average 15.67/device2019-06: 0 reports for this device; peer average 11/device2019-07: 0 reports for this device; peer average 12.6/device2019-08: 0 reports for this device; peer average 24.67/device2019-09: 0 reports for this device; peer average 9.5/device2019-10: 0 reports for this device; peer average 9/device2019-11: 0 reports for this device; peer average 9.5/device2019-12: 0 reports for this device; peer average 13.67/device2020-01: 0 reports for this device; peer average 4.38/device2020-02: 0 reports for this device; peer average 10.4/device2020-03: 0 reports for this device; peer average 9.75/device2020-04: 0 reports for this device; peer average 14.75/device2020-05: 0 reports for this device; peer average 6/device2020-06: 0 reports for this device; peer average 2.6/device2020-07: 0 reports for this device; peer average 3.6/device2020-08: 0 reports for this device; peer average 3.38/device2020-09: 0 reports for this device; peer average 1.87/device2020-10: 0 reports for this device; peer average 3.22/device2020-11: 0 reports for this device; peer average 2.36/device2020-12: 0 reports for this device; peer average 3.4/device2021-01: 0 reports for this device; peer average 2.91/device2021-02: 0 reports for this device; peer average 3/device2021-03: 0 reports for this device; peer average 3.5/device2021-04: 0 reports for this device; peer average 3.5/device2021-05: 0 reports for this device; peer average 4/device2021-06: 0 reports for this device; peer average 3.08/device2021-07: 0 reports for this device; peer average 4.58/device2021-08: 0 reports for this device; peer average 4/device2021-09: 0 reports for this device; peer average 2.5/device2021-10: 0 reports for this device; peer average 3.58/device2021-11: 0 reports for this device; peer average 3.45/device2021-12: 0 reports for this device; peer average 4.5/device2022-01: 0 reports for this device; peer average 3.29/device2022-02: 0 reports for this device; peer average 2.8/device2022-03: 0 reports for this device; peer average 3.67/device2022-04: 0 reports for this device; peer average 2.15/device2022-05: 0 reports for this device; peer average 1.78/device2022-06: 0 reports for this device; peer average 4/device2022-07: 0 reports for this device; peer average 2.83/device2022-08: 0 reports for this device; peer average 2.7/device2022-09: 0 reports for this device; peer average 2.75/device2022-10: 0 reports for this device; peer average 3.33/device2022-11: 0 reports for this device; peer average 2.18/device2022-12: 0 reports for this device; peer average 2.13/device2023-01: 0 reports for this device; peer average 2.27/device2023-02: 0 reports for this device; peer average 2.42/device2023-03: 0 reports for this device; peer average 2.47/device2023-04: 0 reports for this device; peer average 2.28/device2023-05: 0 reports for this device; peer average 1.56/device2023-06: 0 reports for this device; peer average 2.85/device2023-07: 0 reports for this device; peer average 2.75/device2023-08: 0 reports for this device; peer average 2.11/device2023-09: 0 reports for this device; peer average 2.05/device2023-10: 0 reports for this device; peer average 3.58/device2023-11: 0 reports for this device; peer average 2.22/device2023-12: 0 reports for this device; peer average 1.91/device2024-01: 0 reports for this device; peer average 2.07/device2024-02: 0 reports for this device; peer average 2.76/device2024-03: 0 reports for this device; peer average 2.75/device2024-04: 0 reports for this device; peer average 4.72/device2024-05: 0 reports for this device; peer average 2.61/device2024-06: 0 reports for this device; peer average 2.58/device2024-07: 0 reports for this device; peer average 3.05/device2024-08: 0 reports for this device; peer average 3.33/device2024-09: 0 reports for this device; peer average 3.33/device2024-10: 0 reports for this device; peer average 3.42/device2024-11: 0 reports for this device; peer average 3.28/device2024-12: 0 reports for this device; peer average 2.28/device2025-01: 0 reports for this device; peer average 6.46/device2025-02: 0 reports for this device; peer average 6.95/device2025-03: 0 reports for this device; peer average 2.59/device2025-04: 0 reports for this device; peer average 2.5/device2025-05: 0 reports for this device; peer average 2.48/device2025-06: 0 reports for this device; peer average 2.89/device2025-07: 0 reports for this device; peer average 3.11/device2025-08: 0 reports for this device; peer average 4.05/device2025-09: 0 reports for this device; peer average 2.85/device2025-10: 0 reports for this device; peer average 9.4/device2025-11: 0 reports for this device; peer average 3.08/device2025-12: 0 reports for this device; peer average 6.56/device2026-01: 0 reports for this device; peer average 7.11/device2026-02: 0 reports for this device; peer average 4.38/device2026-03: 0 reports for this device; peer average 16.38/device2026-04: 0 reports for this device; peer average 12.28/device2026-05: 0 reports for this device; peer average 19.41/device2026-06: 0 reports for this device; peer average 10.38/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0105
2019-02011.5
2019-0308.71
2019-0407.44
2019-05015.67
2019-06011
2019-07012.6
2019-08024.67
2019-0909.5
2019-1009
2019-1109.5
2019-12013.67
2020-0104.38
2020-02010.4
2020-0309.75
2020-04014.75
2020-0506
2020-0602.6
2020-0703.6
2020-0803.38
2020-0901.87
2020-1003.22
2020-1102.36
2020-1203.4
2021-0102.91
2021-0203
2021-0303.5
2021-0403.5
2021-0504
2021-0603.08
2021-0704.58
2021-0804
2021-0902.5
2021-1003.58
2021-1103.45
2021-1204.5
2022-0103.29
2022-0202.8
2022-0303.67
2022-0402.15
2022-0501.78
2022-0604
2022-0702.83
2022-0802.7
2022-0902.75
2022-1003.33
2022-1102.18
2022-1202.13
2023-0102.27
2023-0202.42
2023-0302.47
2023-0402.28
2023-0501.56
2023-0602.85
2023-0702.75
2023-0802.11
2023-0902.05
2023-1003.58
2023-1102.22
2023-1201.91
2024-0102.07
2024-0202.76
2024-0302.75
2024-0404.72
2024-0502.61
2024-0602.58
2024-0703.05
2024-0803.33
2024-0903.33
2024-1003.42
2024-1103.28
2024-1202.28
2025-0106.46
2025-0206.95
2025-0302.59
2025-0402.5
2025-0502.48
2025-0602.89
2025-0703.11
2025-0804.05
2025-0902.85
2025-1009.4
2025-1103.08
2025-1206.56
2026-0107.11
2026-0204.38
2026-03016.38
2026-04012.28
2026-05019.41
2026-06010.38
This device (reports/month)Average device in LLZ (reports/device/month)

Regulatory clearances

  • K110834 SESE 2011-04-26 (k number procode)

Predicate lineage

K110834 — cited as predicate by K141074, K142736, K151212, K152352, K163281, K193261, K193281, K210807, K211180, K223490, K223514, K243446

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — GE MEDICAL SYSTEMS

  • NAI 2022-09-29 GE Medical Systems, LLC · 0 citations
  • VAI 2018-06-14 GE Medical Systems, LLC · 0 citations
  • NAI 2016-10-11 GE MEDICAL SYSTEMS, LLC · 0 citations
  • NAI 2014-11-10 GE Medical Systems, LLC · 0 citations
  • VAI 2014-02-28 GE Medical Systems, LLC · 1 citations
  • VAI 2013-06-17 GE Medical Systems, LLC · 1 citations
  • NAI 2012-10-11 GE Medical Systems, LLC · 0 citations
  • VAI 2012-03-02 GE Medical Systems, LLC · 7 citations
  • VAI 2011-01-11 GE Medical Systems, LLC · 3 citations
  • NAI 2010-04-26 GE Medical Systems, LLC · 0 citations
  • NAI 2010-01-29 GE Medical Systems, LLC · 0 citations