GE Centricity Web Software Recalled for Patient Safety Concerns
GE Healthcare is recalling Centricity Web software due to an issue with rejected images that may impact patient safety.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source text explicitly states the issue 'may impact patient safety' but does not report specific injuries, illnesses, or deaths. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare is recalling 53 units of GE Centricity Web software, version 3.0x. The software is an image and information distribution system intended for use under the direct supervision of a licensed healthcare practitioner for the clinical review of medical images and reports.
The recall is due to an issue associated with rejected images using the WADO (Web Access to DICOM Objects) protocol. This interface allows for embedding DICOM images as JPEGs on a web page. The issue may impact patient safety when rejected images are archived by Centricity PACS to Enterprise Archive.
The affected units were distributed in the United States, including the states of CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI. Healthcare facilities should contact GE Healthcare for further instructions on how to address this issue.
The recalled product
- Product
- The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricit
- Manufacturer
- Ge Healthcare It
- Category
- Medical Device — Software
- Hazard
- Affected units
- 53
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software versions: 3.0.x
Distribution
Related recalls
Same manufacturer · Ge Healthcare It
See all →- ModerateGE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Loss Risk
FDA (Devices) · 2016-09-14
- HighGE Healthcare Recalls Centricity Laboratory Software Due to Data Deletion Errors
FDA (Devices) · 2016-09-07
- ModerateGE Centricity PACS Workstation Recalled for Image Grouping Errors
FDA (Devices) · 2016-08-24
- HighGe Healthcare Recalls Imagecast PACS Software Due to Image Context Defect
FDA (Devices) · 2016-08-03
- ModerateGE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Loss Risk
FDA (Devices) · 2014-12-31
Same hazard · patient safety
See all →- HighDatex-Ohmeda Auxiliary Common Gas Outlet Conversion Kits Recalled
FDA (Devices) · 2024-10-30
- HighPhilips Ingenia Elition S MRI systems may have incorrectly installed patient support floor plates
FDA (Devices) · 2024-04-24
- HighIngenia 1.5T Patient Trolley Wheels May Attract to MRI Magnetic Field
FDA (Devices) · 2024-02-14
- HighPatient lift device may lose horizontal positioning control, creating fall risk
FDA (Devices) · 2021-10-06
- HighCarl Zeiss Meditec Recalls IOLMaster 700 Devices Due to Patient Data Mismatch
FDA (Devices) · 2021-02-24