Ge Medical Systems Information Technologies
465 PAN AMERICAN DR STE 11, EL PASO, TX, US
Registered product codes
39 product codes
Recent MDR events
550 on file
- GE TELEMETRY MONITORING SYSTEMJan 26, 2026DeathMW5182712
- MAC VU360Nov 25, 2025InjuryMW5179409
- VITAL SIGNS INVASIVE BLOOD PRESSURE CABLENov 6, 2025Malfunction23490854
- MAC VU360Oct 28, 2025InjuryMW5178101
- GE HEALTHCARE MAC VU360Sep 8, 2025InjuryMW5175727
- MACMay 16, 2025Malfunction22034460
- MACMay 15, 2025Malfunction22024585
- MACMay 15, 2025Malfunction22024594
- MACMay 15, 2025Malfunction22024630
- MACMay 15, 2025Malfunction22024752
Recalls
24 on file
- Open, ClassifiedAug 4, 2026
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 previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.
View FDA record ↗ - Open, ClassifiedAug 4, 2026
Portrait Core Services Software version V1.2.0 Security Vulnerability
View FDA record ↗ - Open, ClassifiedJun 1, 2026
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 printer paper. Ignition of the paper could potentially result in serious thermal injury.
View FDA record ↗ - Open, ClassifiedMay 28, 2026
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 NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
View FDA record ↗ - Open, ClassifiedMay 28, 2026
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 NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
View FDA record ↗ - Open, ClassifiedMay 28, 2026
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 NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
View FDA record ↗ - Open, ClassifiedMay 28, 2026
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 NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
View FDA record ↗ - Open, ClassifiedMay 28, 2026
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 NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
View FDA record ↗ - Open, ClassifiedMay 28, 2026
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 NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
View FDA record ↗ - Open, ClassifiedJun 10, 2025
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.
View FDA record ↗
Compliance history
Matched by FEI 3002737156.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.