GE Medical Systems Information Technologies Inc recalls GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA;…
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF…
Read the official notice →- Date
- 2026-06-03
- Country
- United States
- Brand
- GE Medical Systems Information Technologies
- Product
- GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih…
- Classification
- Class II
- Units
- Worldwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Information Technologies recalls
- 2026-08-12
USGE Medical Systems Information Technologies Inc recalls GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information…
FDA · DeviceGE Medical Systems Information Technologies IncWorldwide - US Nationwide distribution in the state of MI, and the countries…Official notice →- US
GE Medical Systems Information Technologies Inc recalls GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a…
FDA · DeviceGE Medical Systems Information Technologies IncWorldwide distribution - US Nationwide and the countries of Belgium, Hong…Official notice → - 2026-06-10
- US
GE Medical Systems Information Technologies Inc recalls CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal…
FDA · DeviceGE Medical Systems Information Technologies IncWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - 2025-06-18
- US
GE Medical Systems Information Technologies Inc recalls MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer…
The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.
FDA · DeviceGE Medical Systems Information Technologies IncWorldwide - US Nationwide distribution.Official notice → - 2024-07-10
- US
GE Medical Systems Information Technologies Inc recalls Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab…
Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.
FDA · DeviceGE Medical Systems Information Technologies IncWorldwide - US Nationwide distribution in the states of AK, AZ, CA, CO, FL,…Official notice → - 2024-06-12
- US
GE Medical Systems Information Technologies Inc recalls GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB…
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
FDA · DeviceGE Medical Systems Information Technologies IncUS Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL,…Official notice →
Other drugs & medical recalls in the United States
- 2026-06-10
- US
Eugia US LLC recalls Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor,…
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
- 2026-06-03
- US
Medline Industries, LP recalls Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer…
FDA · DeviceMedline Industries, LPUS Nationwide distribution in the states of California.Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222),…
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Canada,…Official notice → - US
Medtronic Neuromodulation recalls Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and The countries of Austria, France,…Official notice → - US
Devicor Medical Products Inc recalls HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
FDA · DeviceDevicor Medical Products IncWorldwide distribution - US Nationwide and the countries of Canada, Singapore.Official notice → - US
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,…
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper…
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Denmark,…Official notice →