Drugs & medicalClass II

GE Medical Systems, SCS recalls AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2

Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.

Read the official notice →
Date
2025-10-15
Country
United States
Brand
GE Medical Systems, SCS
Product
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Classification
Class II
Units
Domestic US distribution nationwide. International distribution worldwide.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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, SCS recalls

  1. 2026-07-01
  2. US
    Drugs & medicalClass II

    GE Medical Systems SCS recalls GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System

    GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g.…

    FDA · DeviceGE Medical Systems SCSWorldwide distribution - United States Nationwide and the countries of…Official notice →
  3. 2024-05-15
  4. US
    Drugs & medicalClass II

    GE Medical Systems, SCS recalls GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems

    GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could…

    FDA · DeviceGE Medical Systems, SCSWorldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA,…Official notice →
  5. 2024-02-14
  6. US
    Drugs & medicalClass II

    GE Medical Systems, SCS recalls Senographe Pristina

    X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

    FDA · DeviceGE Medical Systems, SCSUs Nationwide-Worldwide DistributionOfficial notice →
All 4 GE Medical Systems, SCS recalls →

Other drugs & medical recalls in the United States

  1. 2025-10-15
  2. US
    Drugs & medicalClass II

    LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve…

    Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

    FDA · DeviceLeMaitre Vascular, Inc.No US distribution. International distribution to Great Britian and Switzerland.Official notice →
  3. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.

    Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.

    FDA · DeviceBeckman Coulter Inc.US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico SingaporeOfficial notice →
  4. US
    Drugs & medicalClass I

    Abiomed, Inc. recalls Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1.…

    Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).

    FDA · DeviceAbiomed, Inc.Nationwide distribution. International distribution to United Arab Emirates,…Official notice →
  5. US
    Drugs & medicalClass II

    FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

    It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated…

    FDA · DeviceFUJIFILM Healthcare Americas CorporationDomestic: AK, CA, FL, IL, MA, NH, OH, WI.Official notice →
  6. US
    Drugs & medicalClass II

    Fresenius Medical Care Holdings, Inc. recalls Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX…

    To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the…

    FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution.Official notice →
  7. US
    Drugs & medicalClass II

    CORNEAT VISION, LTD. recalls CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

    Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

    FDA · DeviceCORNEAT VISION, LTD.Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC,…Official notice →
See all drugs & medical recalls →