GE Healthcare (China) Co., Ltd.

Complete recall history across all FDA and CPSC categories — 24 total recalls

GE Healthcare (China) Co., Ltd. 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 (24)

FDA medical device enforcement actions by GE Healthcare (China) Co., Ltd.

Date Product Reason Class
Jan 31, 2025 Optima MR360, NMRI system For certain MR systems, a scan can be resumed following a Power Monitor trip ... Class II
Jan 31, 2025 SIGNA MR380, NMRI system, Non-US Only For certain MR systems, a scan can be resumed following a Power Monitor trip ... Class II
Jan 31, 2025 SIGNA MR355, SIGNA MR360, NMRI system For certain MR systems, a scan can be resumed following a Power Monitor trip ... Class II
Jan 31, 2025 SIGNA Creator, SIGNA Explorer, NMRI systems For certain MR systems, a scan can be resumed following a Power Monitor trip ... Class II
Jan 31, 2025 Brivo MR355, NMRI system For certain MR systems, a scan can be resumed following a Power Monitor trip ... Class II
Nov 5, 2024 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography s... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomogr... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed t... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tom... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/comput... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/comp... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomogr... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomograph... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomogr... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomogra... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Nov 5, 2024 GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomogra... GE HealthCare has become aware of a potential issue on certain Discovery, Opt... Class II
Oct 24, 2024 GE Proteus XR/A radiographic system Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by G... Class II
Jul 12, 2024 GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: ... The XR system, Proteus XR/a, does not have a de-installation manual describin... Class II

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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