GE Healthcare

Complete recall history across all FDA and CPSC categories — 89 total recalls

GE Healthcare appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (89)

FDA medical device enforcement actions by GE Healthcare. Showing most recent 50.

Date Product Reason Class
Jan 16, 2026 GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Number... Under certain workflows, patient information shown in the viewer may not matc... Class II
Feb 19, 2025 GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077... There is a potential security vulnerability in Centricity Universal Viewer (U... Class II
Feb 19, 2025 GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 203... There is a potential security vulnerability in Centricity Universal Viewer (U... Class II
Feb 19, 2025 GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 202229... There is a potential security vulnerability in Centricity Universal Viewer (U... Class II
Feb 19, 2025 GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001;... There is a potential security vulnerability in Centricity Universal Viewer (U... Class II
Feb 19, 2025 GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numb... There is a potential security vulnerability in Centricity Universal Viewer (U... Class II
Oct 3, 2024 GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1... GE HealthCare has become aware of an issue in Centricity Universal Viewer Zer... Class II
Aug 29, 2024 GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalo... GE HealthCare has become aware of an issue in Centricity Universal Viewer Zer... Class II
Aug 5, 2024 GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging proces... GE HealthCare has become aware of an issue where image storage is not possibl... Class II
Jul 23, 2024 GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbe... Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addend... Class II
Sep 14, 2023 Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiologica... GE HealthCare has become aware of an issue where images from two different pa... Class II
Sep 14, 2023 Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Rad... GE HealthCare has become aware of an issue where images from two different pa... Class II
Sep 14, 2023 Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW found... GE HealthCare has become aware of an issue where images from two different pa... Class II
Sep 8, 2023 Centricity Universal Viewer Workflow Manager, Image processing radiological s... When using Universal Viewer or Centricity Universal Viewer with Workflow Mana... Class II
Sep 8, 2023 Universal Viewer Workflow Manager, Image processing radiological system When using Universal Viewer or Centricity Universal Viewer with Workflow Mana... Class II
Mar 28, 2023 Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2... GE HealthCare has become aware of an issue where information from two differe... Class II
Mar 28, 2023 Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog ... GE HealthCare has become aware of an issue where information from two differe... Class II
Mar 28, 2023 Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-... GE HealthCare has become aware of an issue where information from two differe... Class II
May 8, 2020 The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images o... GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic m... Class II
Feb 23, 2018 GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 204958... A database handling error could occur during the image acquisition process af... Class II
Jan 25, 2018 Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW wit... Potential that one or more image series may be missing from an exam without... Class II
Jan 25, 2018 Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricit... Potential that one or more image series may be missing from an exam without... Class II
Sep 28, 2015 The Centricity PACS-IW with Universal Viewer is a device that displays medica... Inaccurate distance measurements with magnified projection X-ray images. Class II
Sep 28, 2015 The Centricity Universal Viewer Version is a device that displays medical ima... Inaccurate distance measurements with magnified projection X-ray images. Class II
Sep 16, 2015 Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device tha... Images may be missing when a system parameter MapRoute is set to a value gr... Class II
Aug 31, 2015 GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for di... When performing head or neck scans, the currently displayed SAR values could ... Class II
Aug 31, 2015 GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system... When performing head or neck scans, the currently displayed SAR values could ... Class II
Aug 31, 2015 GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a... When performing head or neck scans, the currently displayed SAR values could ... Class II
Aug 31, 2015 GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR syst... When performing head or neck scans, the currently displayed SAR values could ... Class II
Aug 31, 2015 GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family ... When performing head or neck scans, the currently displayed SAR values could ... Class II
Aug 31, 2015 GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging ... When performing head or neck scans, the currently displayed SAR values could ... Class II
Aug 31, 2015 GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 ... When performing head or neck scans, the currently displayed SAR values could ... Class II
Aug 11, 2015 Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PA... Images from the Centricity PACS-IW with Universal Viewer and Centricity Univ... Class II
Aug 11, 2015 Centricity Universal Viewer Product Usage: The Centricity Universal Viewe... Images from the Centricity PACS-IW with Universal Viewer and Centricity Univ... Class II
Jul 17, 2015 PET Discovery ST 16 Potential for expulsion of the Power Supply on Lightspeed CT scanner or Disco... Class II
Jul 17, 2015 PET Discovery LS Potential for expulsion of the Power Supply on Lightspeed CT scanner or Disco... Class II
Jul 17, 2015 Lightspeed 16 CT Potential for expulsion of the Power Supply on Lightspeed CT scanner or Disco... Class II
Jul 10, 2015 GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; Ec... A gradient cable in the ACGD cabinet may be missing a spacer that prevents co... Class II
Jun 12, 2015 GE Healthcare, Precision MPi fluoroscopic imaging systems. A reported incident of a monitor that fell from the suspension. A fall of a ... Class II
Jun 12, 2015 GE Healthcare Precision RXi Digital system A reported incident of a monitor that fell from the suspension. A fall of a ... Class II
Jun 12, 2015 GE Healthcare Precision RXi 23A/32A Analog System A reported incident of a monitor that fell from the suspension. A fall of a ... Class II
Jun 12, 2015 GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Flu... The SFD/IDD safety mechanism may not engage properly at the lower range of SF... Class II
Jun 12, 2015 GE Healthcare Precision 500D Classical R & F system. A reported incident of a monitor that fell from the suspension. A fall of a ... Class II
May 29, 2015 GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may ... Class II
May 29, 2015 GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may ... Class II
May 29, 2015 GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may ... Class II
May 29, 2015 GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiograph... GE Healthcare has recently become aware of a potential safety issue that may ... Class II
May 29, 2015 GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may ... Class II
May 29, 2015 GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may ... Class II
May 29, 2015 GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may ... Class II

View all 89 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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