GE Healthcare, LLC
Complete recall history across all FDA and CPSC categories — 474 total recalls
GE Healthcare, LLC 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 (474)
FDA medical device enforcement actions by GE Healthcare, LLC. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 15, 2022 | (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity ... | Inaccurate Distance and Area measurements with use of Global Stack viewport. | Class II |
| Jun 24, 2022 | SIGNA Premier magnetic resonance scanner, model 5748519. | Under rare conditions, SIGNA Premier gradient coils could result in elevated ... | Class II |
| Jun 14, 2022 | Centricity PACS Software Version 7.0 SP0.0.4.7 | The Event Notification Manager (ENM) functionality for certain products does ... | Class II |
| Jun 8, 2022 | GE Centricity Universal Viewer Zero Footprint. To view, communicate, proces... | Potential to display inaccurate measurements on images in Centricity Universa... | Class II |
| Jun 2, 2022 | Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT170... | As a result of unclear guidance in the service manual, the table can drop dur... | Class II |
| Jun 1, 2022 | GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Ava... | There is a potential reversal of the O2 and air cylinder pressure transducer ... | Class I |
| May 27, 2022 | GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-... | The base of the anesthesia system can have a crack and could potentially frac... | Class II |
| May 10, 2022 | CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-00... | The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power... | Class II |
| Apr 28, 2022 | Centricity PACS RA1000 | Potential for Distance and Area measurements to display inaccurate measuremen... | Class II |
| Apr 28, 2022 | Centricity Cardiology CA1000 | Potential for Distance and Area measurements to display inaccurate measuremen... | Class II |
| Apr 28, 2022 | Centricity Enterprise Web | Potential for Distance and Area measurements to display inaccurate measuremen... | Class II |
| Apr 28, 2022 | Centricity Universal Viewer Zero Footprint Client | Potential for Distance and Area measurements to display inaccurate measuremen... | Class II |
| Apr 28, 2022 | Centricity Radiology RA600 | Potential for Distance and Area measurements to display inaccurate measuremen... | Class II |
| Apr 25, 2022 | Field replacement back up batteries distributed on or after April 1, 2019 for... | Backup batteries can fail earlier than their estimated life. | Class II |
| Apr 25, 2022 | Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufac... | Backup batteries can fail earlier than their estimated life. | Class II |
| Apr 18, 2022 | Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 ... | Insufficient battery backup power resulting in premature shutdown of the vent... | Class I |
| Apr 18, 2022 | Replacement back up batteries distributed on or after April 1, 2019, for CARE... | Insufficient battery backup power resulting in premature shutdown of the vent... | Class I |
| Mar 16, 2022 | MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 310101... | Two scenarios may cause edits to measurements and diagnosis statements can be... | Class II |
| Mar 4, 2022 | GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier,... | During the de-installation of an MR system magnet, if all rigging and hardwar... | Class II |
| Feb 18, 2022 | 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile... | There is potential for the images to be flipped left to right. | Class II |
| Feb 18, 2022 | 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System | There is potential for the images to be flipped left to right. | Class II |
| Feb 18, 2022 | SIGNA Excite 3T. Magnetic Resonance Imaging System | There is potential for the images to be flipped left to right. | Class II |
| Feb 18, 2022 | Signa 1.5T TwinSpeed Magnetic Resonance Imaging System | There is potential for the images to be flipped left to right. | Class II |
| Jan 28, 2022 | GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF... | If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, th... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Contou... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Discov... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Discov... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo ... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with E... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vec... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthon... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Discov... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo ... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infini... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T S... | The magnetic resonance systems could potentially have a cryogen ventilation s... | Class II |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation s... | 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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