GE Healthcare It

FDA recalling firm · 17 enforcement events · 17 product records · 2011–2013 · IL

GE Healthcare It has 17 FDA enforcement events on this register (17 product records) between 2011 and 2013: 17 device; the busiest year was 2012 with 9.

0% of its events are Class I; the most common class is Class II (16). 0 events are listed as ongoing; the recalling firm's address is in IL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
26 Aug 2013	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. Two and three dimensional image review,…	Device	Class II	1	Terminated
11 Jun 2013	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 workstation throughout the healthcare…	Device	Class II	1	Terminated
19 Apr 2013	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 that other systems have with the…	Device	Class II	1	Terminated
12 Mar 2013	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 results. It is a specially designed data…	Device	Class II	1	Terminated
12 Mar 2013	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 results. It is a specially designed data…	Device	Class II	1	Terminated
11 Mar 2013	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 be used in physicians offices and…	Device	Class II	1	Terminated
18 Feb 2013	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 purpose computing hardware to acquire,…	Device	Class II	1	Terminated
20 Nov 2012	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., the storing and delivering of analytical…	Device	Class II	1	Terminated
20 Nov 2012	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 results. It is a specially designed data…	Device	Class II	1	Terminated
20 Nov 2012	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 results. It is a specially designed data…	Device	Class III	1	Terminated
16 Nov 2012	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 (published by ACR-NEMA). The clinical…	Device	Class II	1	Terminated
15 Nov 2012	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 and nurses. Also used as a clinical review…	Device	Class II	1	Terminated
2 Oct 2012	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 information from various data sources. Information…	Device	Class II	1	Terminated
15 Sep 2012	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, technologists, clinicians and nurses. It is also…	Device	Class II	1	Terminated
15 Jun 2012	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 at distributed locations. Lossy…	Device	Class II	1	Terminated
19 Apr 2012	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 Centricity Enterprise Web is not intended for…	Device	Class II	1	Terminated
4 Mar 2011	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 throughout a clinical environment. Data…	Device	Class II	1	Terminated

By type and class

Device17

Class II16

Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for GE Healthcare It by year initiated.

Questions and answers

How many FDA recalls has GE Healthcare It had?

17 enforcement events (17 product records) on this register, 2011–2013: 17 device.

Are any GE Healthcare It recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are GE Healthcare It recalls?

16 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.