Centricity Pacs System

• 6 recalls, same reason

  • Ongoing Z-3168-2026 FDA Class II ·initiated 31 Jul 2026
  • Ongoing Z-3166-2026 FDA Class II ·initiated 31 Jul 2026
  • Ongoing Z-3170-2026 FDA Class II ·initiated 31 Jul 2026
  • Ongoing Z-3167-2026 FDA Class II ·initiated 31 Jul 2026
  • Ongoing Z-3171-2026 FDA Class II ·initiated 31 Jul 2026
  • Ongoing Z-3169-2026 FDA Class II ·initiated 31 Jul 2026

  Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

• • Ongoing Z-3214-2024 FDA Class II ·initiated 5 Aug 2024

  GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study.

• • Terminated Z-1665-2014 FDA Class II ·initiated 3 Apr 2014

  It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed study, images for the previously displayed study may also be rejected. The issue can occur with a previously displayed study that remains open in the background. If one or more, but not all, images in

• • Terminated Z-0116-2014 FDA Class II ·initiated 11 Jun 2013

  GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS-Driven integration, the "close" button closes the exam in RIS-IC, but does not close the exam in Centricity PACS RA1000 Workstation. 2) Interrupted workflow could break the

• • Terminated Z-1214-2015 FDA Class II ·initiated 18 Feb 2013

  Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on &amp

• • Terminated Z-2579-2016 FDA Class II ·initiated 15 Nov 2012

  While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors.

• • Terminated Z-0731-2014 FDA Class II ·initiated 15 Sep 2012

  There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. When another process in the destination server attempts to access the same object or table, the transfer process of a particular image may be terminated. Once ter

• • Terminated Z-0456-2010 FDA Unclassified (pre-2012) ·initiated 25 Sep 2009

  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.

• • Terminated Z-1549-2009 FDA Unclassified (pre-2012) ·initiated 3 Apr 2009

  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.

• • Terminated Z-1543-2009 FDA Unclassified (pre-2012) ·initiated 24 Mar 2009

  Software anomalies may allow the image orientation to be misinterpreted, posing a potential patient safety issue.

• • Terminated Z-0969-2009 FDA Unclassified (pre-2012) ·initiated 12 Jan 2009

  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.

• • Terminated Z-0836-2009 FDA Unclassified (pre-2012) ·initiated 12 Dec 2008

  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.

• • Terminated Z-0928-2009 FDA Unclassified (pre-2012) ·initiated 21 Nov 2008

  There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed.

• • Terminated Z-0970-2009 FDA Unclassified (pre-2012) ·initiated 20 Nov 2008

  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.

• • Terminated Z-0460-2009 FDA Unclassified (pre-2012) ·initiated 25 Sep 2008

  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

• • Terminated Z-1826-2008 FDA Unclassified (pre-2012) ·initiated 6 May 2008

  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.

• • Terminated Z-1104-2008 FDA Unclassified (pre-2012) ·initiated 28 Dec 2007

  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.

• • Terminated Z-0373-2007 FDA Unclassified (pre-2012) ·initiated 12 Jan 2007

  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.

1. 18 Feb 2013 Recall initiated FDA recalls Z-1214-2015
2. 11 Jun 2013 Recall initiated FDA recalls Z-0116-2014
3. 3 Apr 2014 Recall initiated FDA recalls Z-1665-2014
4. 5 Aug 2024 Recall initiated FDA recalls Z-3214-2024
5. 31 Jul 2026 Recall initiated FDA recalls Z-3168-2026
6. 31 Jul 2026 Recall initiated FDA recalls Z-3166-2026
7. 31 Jul 2026 Recall initiated FDA recalls Z-3170-2026
8. 31 Jul 2026 Recall initiated FDA recalls Z-3167-2026
9. 31 Jul 2026 Recall initiated FDA recalls Z-3171-2026
10. 31 Jul 2026 Recall initiated FDA recalls Z-3169-2026

14 earlier events are in the sections above.

510(k) Number

K043415 ↗

FDA product code

LLZ

Device class

Class II

Regulation

21 CFR Part 892.2050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

• DTX Studio diagnose by Nobel Biocare AB
• QCA PLUS by Sanders Data Systems, LLC
• Sterile Sheath for CONVIVO 302732-0530-000 by Carl Zeiss Meditec AG
• PROVIEW MEDICAL IMAGE DISPLAY MODULE by Cerner Corporation
• Surgical Planning Software version 1.1 by ORTHO KINEMATICS, INC.
• VISUALASE ENVISION SOFTWARE SYSTEM by BIOTEX, INC.
• VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER by Vidistar, LLC
• Blackford Analysis Registration Product Family by Blackford Analysis, Ltd.
• KODAK CARESTREAM PACS by EASTMAN KODAK COMPANY
• SYNAPSE 3D TENSOR ANALYSIS by Fujifilm Meidcal Systems U.S.A., Inc.

• Mac VU360

  Class IIa

  CE/MDR

• Carescape Central Station Software Version 4

  Class IIb

  CE/MDR

• Carescape Central Station MAI800 Open recall

  Class II

  CE/MDR FDA 510(k) K162012 Active Cleared 15 Sep 2016 +1authorizations

• CareIntellect Perinatal 2.3

  Class II

  FDA 510(k) K220732 Active Cleared 23 Jun 2022 GUDID on market

See all devices from GE Medical Systems Information Technologies, Inc. →