GE Medical Systems, LLC recalls SIGNA Architect
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result,…
Read the official notice →- Date
- 2025-07-30
- Country
- United States
- Brand
- GE Medical Systems
- Product
- SIGNA Architect
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the country of China.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More GE Medical Systems recalls
- 2025-10-22
USGE Medical Systems, LLC recalls LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
- 2025-09-03
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GE Medical Systems, LLC recalls GE HealthCare OEC 9900 Elite C-arm Systems.
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator…
- 2025-08-20
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GE Medical Systems, LLC recalls GE Signa Artist, Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T,…
- 2025-06-18
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GE Medical Systems, LLC recalls OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional…
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
- 2025-04-23
- US
GE Medical Systems, LLC recalls Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG,…
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
- 2025-03-19
- US
GE Medical Systems, LLC recalls GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol)…
Other drugs & medical recalls in the United States
- 2025-07-30
- US
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalls Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Natus received two complaints of left side labeling show impedance for right side.
FDA · DeviceNatus Neurology DBA Excel Tech., Ltd. (XLTEK)US: CA, IN, MO, NC, PA, RI, TXOfficial notice → - US
CooperSurgical, Inc. recalls Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
FDA · DeviceCooperSurgical, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20. Fluoroscopic X-Ray System.
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution: US (nationwide) to states of: CA, CO, DC, DE, FL, IL,…Official notice → - US
DIGIMED CO., LTD recalls Portable X-ray system
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
- US
Cipla USA, Inc. recalls Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd.…
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
- US
Mckesson Medical-Surgical Inc. Corporate Office recalls EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by:…
CGMP Deviations; potential temperature excursions due to transit delays
FDA · DrugMckesson Medical-Surgical Inc. Corporate OfficeWithin the U.S - OH, VA, FL.Official notice →