GE Healthcare Integrated IT Solutions
Country not established
- Devices
- 4
- FDA recalls
- 20
At a glance
Market reach
- United States
- FDA recalls
What GE Healthcare Integrated IT Solutions makes
The company develops and maintains integrated clinical information systems for healthcare settings, including CENTRICITY PERINATAL and CENTRICITY INTENSIVE CARE solutions for neonatal and critical care monitoring, CENTRICITY CARDIO IMAGING for cardiac diagnostic support, and PACS-IW for radiology workflow management. It also provides specialized imaging platforms like CENTRICITY RADIOLOGY RA600, CENTRICITY CARDIOLOGY CA1000, and digital hardcopy systems for radiology and cardiology departments.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Centricity Cardio Imaging Ref K112570
Regimes: 510(k) Registry: 510(k)Centricity Pacs-Iw Ref K121387
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 20 recalls initiated by Ge Healthcare Integrated IT Solutions, the earliest on 2007-01-12 and the most recent on 2009-09-25. By recorded status: 20 terminated. The reasons filed fall into these groups: labeling or instructions for use and software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 25 Sep 2009 Z-0456-2010 Unclassified (pre-2012) Terminated There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety.
Full distribution text
- 14 Aug 2009 Z-2316-2009 Unclassified (pre-2012) Terminated Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where study split operations are not correctly replicated to a secondary 'shadow' archive.
Full distribution text
- 3 Apr 2009 Z-1549-2009 Unclassified (pre-2012) Terminated There is a potential safety issue associated with the use of GE Centricity PACS software related to configuration of DICOM query retrieval with rejected images.
Full distribution text
- 24 Mar 2009 Z-1543-2009 Unclassified (pre-2012) Terminated Software anomalies may allow the image orientation to be misinterpreted, posing a potential patient safety issue.
Full distribution text
- 12 Jan 2009 Z-0969-2009 Unclassified (pre-2012) Terminated If a user site created a custom default display protocol (DDP) to display the current exam versus the historical exam and the user-defined DDP fails, the system displays the exams using a GE default hanging protocol. This may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars.
- 25 Sep 2009 Z-0456-2010 Unclassified (pre-2012) Terminated There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety.
2008
- 12 Dec 2008 Z-0836-2009 Unclassified (pre-2012) Terminated There is a potential patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it.
Full distribution text
- 12 Dec 2008 Z-0870-2009 Unclassified (pre-2012) Terminated Software error: There are two potential safety situations with Centricity Enterprise Web software - a forced log off may occur while using the Centricity Enterprise Web during an open session, and Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation.
Full distribution text
- 21 Nov 2008 Z-0928-2009 Unclassified (pre-2012) Terminated There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed.
- 20 Nov 2008 Z-0970-2009 Unclassified (pre-2012) Terminated Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam.
- 17 Nov 2008 Z-1397-2009 Unclassified (pre-2012) Terminated A software defect in the Centricity Lab (TriWin) product may incorrectly link patient information to a wrong report. Also, when viewing results in Patient Viewer, and a coagulation result is higher or lower than the linearity limit, then all of the results following the higher or lower result will show the same result as the first flagged result.
- 12 Dec 2008 Z-0836-2009 Unclassified (pre-2012) Terminated There is a potential patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it.
Show all 20 recalls
2008
- 25 Sep 2008 Z-0112-2009 Unclassified (pre-2012) Terminated On the I&O chart, the IN, OUT and NET fluid totals values will not honor the numeric precision configuration, always displaying a whole number, losing decimal point accuracy.
- 25 Sep 2008 Z-0456-2009 Unclassified (pre-2012) Terminated Software anomalies in the Alert and Reminder feature could result in a delay of treatment. When attempting to select the last visible alert or reminder choice, the next choice on the list below the desired choice is selected, and an inconsistent color may be displayed for the same clinical element across a set of work stations.
- 25 Sep 2008 Z-0460-2009 Unclassified (pre-2012) Terminated Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the curr
Full distribution text
- 22 Sep 2008 Z-0472-2009 Unclassified (pre-2012) Terminated Software computer, error: The abnormal result flag is not being sent in the HL7 messages on results that are lower than the normal range. For further information, please telephone GE Healthcare Integrated IT Solutions at 800-437-1171.
- 30 Jun 2008 Z-2037-2008 Unclassified (pre-2012) Terminated Patient information mix-up: When the PFILS application, configured with a backup server has experienced a network interruption, PFILS verify could result in the Centricity Perinatal application recording non-identifiable patient information to the incorrect patient file.
- 11 Jun 2008 Z-2183-2008 Unclassified (pre-2012) Terminated When using any vessel analysis protocol of the AW Suite Card IQ application, the software can reload saved tracking objects (Save State) incorrectly and display an incorrect vessel label over the restored images. This failure only occurs when users create a custom label in the vessel analysis protocol and include leading or trailing blank characters (space bar) in the custom label.
Full distribution text
- 9 May 2008 Z-1825-2008 Unclassified (pre-2012) Terminated Incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta protocol or customized protocol of the Centricity AW Suite 2.0 running on the Centricity RA 1000 or RA600/CA1000 workstations.
Full distribution text
- 6 May 2008 Z-1826-2008 Unclassified (pre-2012) Terminated A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis.
Full distribution text
2007
- 28 Dec 2007 Z-1104-2008 Unclassified (pre-2012) Terminated Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe [']). This may not be evident to the end user, as the symbols only appear when the Exam Note window is open.
Full distribution text
- 12 Jan 2007 Z-0373-2007 Unclassified (pre-2012) Terminated The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential.
Full distribution text
- 28 Dec 2007 Z-1104-2008 Unclassified (pre-2012) Terminated Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe [']). This may not be evident to the end user, as the symbols only appear when the Exam Note window is open.
Frequently asked questions
How many devices does Ge Healthcare Integrated IT Solutions have in the registry?
The registry currently lists 4 devices for Ge Healthcare Integrated IT Solutions. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ge Healthcare Integrated IT Solutions's devices?
Among its 4 most recently registered devices, Ge Healthcare Integrated IT Solutions has devices listed in FDA 510(k) (4 devices).
What risk classes do Ge Healthcare Integrated IT Solutions's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Ge Healthcare Integrated IT Solutions's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ge Healthcare Integrated IT Solutions?
FDA recall records list 20 recalls initiated by Ge Healthcare Integrated IT Solutions, the most recent initiated on 25 Sep 2009. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ge Healthcare Integrated IT Solutions in the registry?
The most recently registered devices listed for Ge Healthcare Integrated IT Solutions include CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE, CENTRICITY CARDIO IMAGING, CENTRICITY PACS-IW and CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY.