AW Server
AW Server 3.2 Medical Device
16manufacturers in China registered for this device type
1catalogue number
19510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological
Record
| Listed by | GE Medical Systems, LLC, United States |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K081985 |
| Record published | 2016-08-01 |
| Record revised | 2023-10-18 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imagegrid Radiology Viewer System | Candelis, Inc. | 173 |
| Tims System | Foresight Imaging, LLC | 159 |
| System, Image Processing, Radiological | Biomet Microfixation | 146 |
| RamSoft | Ramsoft, Inc. | 65 |
| Joints | Medstrat | 62 |
| OrthoView | Meridian Technique Ltd | 54 |
| IPS | KLS-Martin L.P. | 48 |
| NovaPACS | Novarad Corp. | 42 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 34 |
| DTX Studio™ Clinic | Nobel Biocare AB | 34 |
| Eaglesoft | Patterson Technology Center | 33 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143368 | 2015-07-29 |
| K150193 | 2015-03-24 |
| K121762 | 2013-01-18 |
| K103480 | 2011-03-07 |
| K081985 | 2008-09-25 |
| K051673 | 2005-07-18 |
| K024137 | 2003-01-15 |
| K023557 | 2002-11-07 |
| K022310 | 2002-08-01 |
| K020483 | 2002-02-28 |
| K010336 | 2001-02-16 |
| K991629 | 1999-08-02 |
| K983256 | 1998-12-15 |
| K981217 | 1998-06-18 |
| K960265 | 1996-07-03 |
| K960613 | 1996-04-30 |
| K955185 | 1996-01-03 |
| K924310 | 1993-01-21 |
| K902428 | 1990-11-19 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems SCS | 510(k) number | 2026-05-08 | Class II | Software design | GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the applic | 340 servers | |
| GE Medical Systems SCS | 510(k) number | 2025-09-05 | Class II | Software in the Use Environment | Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data. | 7,302 (1,381 US; 5,921 OUS) | |
| GE Medical Systems, LLC | 510(k) number | 2013-09-19 | Class II | Software design | GE 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 t | 1458 (336 US, 1122 OUS) | 2014-07-31 |
| GE Medical Systems, LLC | 510(k) number | 2012-06-28 | Class II | Software design | GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a | 429 | 2014-02-04 |
| GE Medical Systems, LLC | 510(k) number | 2011-11-17 | Not classified | Software design | 2 Unrelated Software Issues: An incorrect patient name maybe displayed when switching between two Volume Viewer tabs with different patients. Also, if a second patient exam is selected while the application is starting, the second patient’ | 308 | 2012-07-03 |
Recalls
38 of these are Class II. Class II means a temporary or reversible health consequence.
Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-01-30 | Class II | Software design | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially i | 1568 units | |
| 2026-01-30 | Class II | Software design | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially i | 40 units | |
| 2026-01-30 | Class II | Software design | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially i | 797 units | |
| 2022-10-28 | Class II | Software Manufacturing/Software Deployment | There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study. | 1 unit | |
| 2022-10-28 | Class II | Software Manufacturing/Software Deployment | There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study. | 236 units | |
| 2022-07-15 | Class II | Process design | Inaccurate Distance and Area measurements with use of Global Stack viewport. | 1,690 devices | |
| 2022-06-14 | Class II | Software design | The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams. | 47 installations | 2024-01-16 |
| 2022-06-08 | Class II | Software design | Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP) | 1,934 units | |
| 2022-04-28 | Class II | Software design | Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy | 601 units | |
| 2022-04-28 | Class II | Software design | Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy | 1,332 units | |
| 2022-04-28 | Class II | Software design | Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy | 536 units | |
| 2022-04-28 | Class II | Software design | Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy | 488 units | |
| 2022-04-28 | Class II | Software design | Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy | 676 units | |
| 2021-10-15 | Class II | Software design | There is a potential to display incomplete patient imaging study. | 638 devices | 2026-08-17 |
| 2021-08-12 | Class II | Other | A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA). | 49 | 2024-08-22 |
| 2021-08-06 | Class II | Software design | Image acquisition failures and synchronization failure with the Centricity Enterprise Archive | 462 (279 US; 183 OUS) | |
| 2021-08-06 | Class II | Software design | Image acquisition failures and synchronization failure with the Centricity Enterprise Archive | 392 (219 US; 173 OUS) all products | |
| 2021-03-19 | Class II | Under Investigation by firm | When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially include a different patient s compariso | 112 units | 2023-08-11 |
| 2019-12-16 | Class II | Software design | Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis. | 205 | 2023-10-05 |
| 2019-05-22 | Class II | Software design | There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer. | 620 units | 2024-09-20 |
| 2019-05-17 | Class II | Software design | There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer. | 50 units | 2023-11-20 |
| 2019-05-17 | Class II | Software design | There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer. | 292 units | 2023-11-20 |
| 2019-05-16 | Class II | Device Design | There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive. | 145 (87 US 103 OUS) | 2023-04-14 |
| 2019-05-16 | Class II | Device Design | There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive. | 92 (47 US 103 OUS) | 2023-04-14 |
| 2018-12-20 | Class II | Software design | When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagn | 297 (131 US; 166 OUS) | 2021-04-09 |
| 2018-11-09 | Class II | Software design | Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and vertically, the orientation markers appear correctly on the image to which they were applied | 508 units | 2026-05-18 |
| 2018-10-11 | Class II | Software design | Synchronization failure | 13 | 2023-03-20 |
| 2018-10-11 | Class II | Software design | Synchronization failure | 73 | 2023-03-20 |
| 2018-08-30 | Class II | Component design/selection | Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present. | 1 | 2022-08-31 |
| 2016-11-21 | Class II | Nonconforming Material/Component | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors – Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems. | Total for all products 1,598 (USA 824, OUS 774) | 2017-09-26 |
| 2014-04-07 | Class II | Software design | GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation. | 101 (1 US , 100 OUS) | 2014-05-29 |
| 2013-08-07 | Class II | Software Design Change | GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system. The ViewPoint cal | 225 | 2014-04-25 |
| 2012-09-20 | Class II | Software design | GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety. | 179 | 2016-07-07 |
| 2012-05-29 | Class II | Software design | GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage worksta | 548 (118 USA; 430 OUS) | 2013-01-17 |
| 2012-05-24 | Class II | Software design | GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the | 188 | 2013-03-26 |
| 2012-05-24 | Class II | Software design | GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two | 70 | 2012-12-06 |
| 2012-05-24 | Class II | Software design | GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size. | 12 | 2012-12-11 |
| 2012-05-24 | Class II | Software design | GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the aorta analysis protocol or the customized | 1055 | 2012-12-11 |
Source: U.S. FDA establishment registration and device listing records, public domain.
Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.