GE Medical Systems Information Technologies Inc recalls Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3…
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
Read the official notice →- Date
- 2026-09-23
- Country
- United States
- Brand
- GE Medical Systems Information Technologies
- Product
- Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number…
- Classification
- Class II
- Units
- Worldwide - US Nationwide 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-09-02
USGE Medical Systems Information Technologies Inc recalls PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings…
FDA · DeviceGE Medical Systems Information Technologies IncUS: MI, NY and Australia, Czech Republic, Finland, Germany, Italy,…Official notice →- 2026-08-12
- US
GE 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 → - 2026-06-03
- US
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…
- 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 →
Other drugs & medical recalls in the United States
- 2026-09-23
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,…
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
FDA · DeviceAbiomed, Inc.Domestic: Nationwide Distribution. International: United Arab Emirates,…Official notice → - US
Bayer Medical Care, Inc. recalls MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
- US
Maquet Cardiopulmonary Gmbh recalls Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
The packaging may not consistently maintain sterile barrier integrity.
FDA · DeviceMaquet Cardiopulmonary GmbhWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Philips North America recalls Philips PIC iX Essentials REF:867093
Due to software malfunction, patient information system may freeze and become unresponsive.
FDA · DevicePhilips North AmericaWorldwide - US Nationwide distribution including in the states and territories…Official notice → - US
Medline Industries, LP recalls Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified…
- US
Nova Biomedical Corporation recalls StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID)…
FDA · DeviceNova Biomedical CorporationWorldwide distribution: US (nationwide) and OUS (foreign) countries of:…Official notice →