Manufacturer

GE Healthcare It

17 recalls in our database name GE Healthcare It as the manufacturing or recalling firm.

What the numbers show

Total: 17
Critical: 0
Severe: 0
Most recent: 2016-09-14

Of the 17 recalls from GE Healthcare It we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–17 of 17

ModerateFDA (Devices)·Z-2739-2016·2016-09-14
GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Loss Risk
GE Healthcare is recalling Centricity Enterprise Archive software version 3.0.x due to a potential for data loss when the cache disk is nearly full.
Product
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2671-2016·2016-09-07
GE Healthcare Recalls Centricity Laboratory Software Due to Data Deletion Errors
GE Healthcare is recalling Centricity Laboratory software versions 3.3 to 4.1 because deleting a slave panel incorrectly removes free-text notes and reference ranges from the master panel.
Product
Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g.,
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2579-2016·2016-08-24
GE Centricity PACS Workstation Recalled for Image Grouping Errors
GE Healthcare is recalling 498 Centricity PACS Workstations due to a software defect that causes random image-series grouping errors when specific exams are opened simultaneously.
Product
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2300-2016·2016-08-03
Ge Healthcare Recalls Imagecast PACS Software Due to Image Context Defect
Ge Healthcare is recalling Imagecast PACS software versions prior to 10.6 Update Package 18 because a defect causes images to be out of context with clinical information.
Product
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general pur
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0833-2015·2014-12-31
GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Loss Risk
GE Healthcare is recalling Centricity Enterprise Archive software versions 4.0.x due to a potential data loss issue associated with HL-7 updates.
Product
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction t
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0865-2014·2014-02-05
GE Centricity Laboratory System Software Recall for Calculation Errors
GE Healthcare is recalling Centricity Laboratory System software due to a defect that may report calculated results as 0 or truncate them.
Product
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical res
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0748-2014·2014-01-22
GE Healthcare Recalls Merge Mammo Workstation Software Due to Image Display Errors
GE Healthcare is recalling 28 units of Merge Mammo software version 8.0.2 because images may display out of sync with the navigator, potentially leading to misdiagnosis.
Product
Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-0731-2014·2014-01-22
GE Centricity PACS System Recalled for Potential Image Loss During Transfer
GE Healthcare is recalling Centricity PACS System versions 3.X and 4.X due to a potential loss of diagnostic images during transfers between servers.
Product
Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technolo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0773-2014·2014-01-22
GE Healthcare Recalls Imagecast PACS Software Due to Measurement Errors
GE Healthcare is recalling Imagecast PACS versions prior to 3.6.51.01 because the software fails to account for the estimated magnification factor, leading to inaccurate distance measurements.
Product
Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data t
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0620-2014·2014-01-08
GE Centricity Laboratory System Recall for Free-Text Data Loss
GE Healthcare is recalling 5 units of the Centricity Laboratory System because free-text data from instruments may be discarded if orders are not yet in the system.
Product
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical res
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0454-2014·2013-12-11
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.
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
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0330-2014·2013-11-27
GE Centricity Laboratory Software Recalled for Panel Reflex Failure
GE Healthcare is recalling Centricity Laboratory System software versions 3.3, 4.0, and 4.1 because panel reflexing may fail under specific conditions.
Product
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical res
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0337-2014·2013-11-27
GE Healthcare Recalls Centricity Perinatal and Intensive Care Software
GE Healthcare is recalling Centricity Perinatal and Intensive Care software due to a rare network issue that may temporarily prevent users from accessing patient rosters.
Product
Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0118-2014·2013-11-06
GE Centricity PACS-IW Software Recall for Patient Safety Risks
GE Healthcare is recalling Centricity PACS-IW software due to issues that could display incorrect patient images or under-report dose values, posing a safety risk to patients.
Product
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks
Category
Medical Device
Distribution
51 states
ModerateFDA (Devices)·Z-0116-2014·2013-11-06
GE Centricity PACS Workstation Recalled for Workflow Interruption Issues
GE Healthcare is recalling 623 Centricity PACS Workstations due to software workflow interruptions that may prevent exams from closing correctly in the system.
Product
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review work
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0034-2014·2013-10-30
GE Healthcare Recalls Centricity Cardio Imaging 5.0 Software
GE Healthcare is recalling Centricity Cardio Imaging 5.0 software due to a potential image labeling error in the Image Viewer that may affect diagnostic interpretation.
Product
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other inform
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1585-2013·2013-07-03
GE Healthcare Recalls Centricity Laboratory System Software Due to Data Loss
GE Healthcare is recalling 9 units of Centricity Laboratory System software versions 3.3, 4.0, and 4.1 because a specific configuration can cause loss of free-text data in microbiology results.
Product
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical res
Category
Medical Device
Distribution
6 states