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GE Medical Systems, LLC

GE Medical Systems, LLC Recalls

All product recalls associated with GE Medical Systems, LLC.

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Recall Summary

Total Recalls

97

Past Year

44

Class I (Serious)

0

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 41–60 of 97 recalls

Definium/Discovery XR656HD (GE) – exposure limit (2025)

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

FDAJan 28, 2025Nationwide• GE Medical Systems, LLC

Discovery XR656 HD X-Ray System (GE) – exposure limit (2025)

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

FDAJan 28, 2025Nationwide• GE Medical Systems, LLC

Discovery XR656HD X-Ray System (GE) – exposure limit (2025)

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

Page 3 of 5Next

Moderate

FDAJan 28, 2025Nationwide• GE Medical Systems, LLC

Optima XR646 HD X-Ray System (GE) – exposure limit (2025)

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

FDAJan 28, 2025Nationwide• GE Medical Systems, LLC

Portrait Core Services (GE Medical) – Patient Monitoring Software Failure (2024)

There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.

FDADec 6, 2024Nationwide• GE Medical Systems, LLC

GE Optima XR220amx (GE Medical) – Column Bolt Issue (2024)

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

FDANov 25, 2024Nationwide• GE Medical Systems, LLC

GE Optima XR240amx (GE Medical) – Column Bolt Issue (2024)

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

FDANov 25, 2024Nationwide• GE Medical Systems, LLC

GE Optima XR200amx (GE Medical) – Column Bolt Issue (2024)

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

FDANov 25, 2024Nationwide• GE Medical Systems, LLC

Tec 820 ISO Vaporizer (GE Medical) – Anesthetic Delivery (2024)

Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.

FDANov 18, 2024Nationwide• GE Medical Systems, LLC

Tec 850 ISO Vaporizer (GE Medical) – Anesthetic Delivery (2024)

Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.

FDANov 18, 2024Nationwide• GE Medical Systems, LLC

Tec 820 SEV Vaporizer (GE Medical) – Anesthetic Delivery (2024)

Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.

FDANov 18, 2024Nationwide• GE Medical Systems, LLC

Tec 850 SEV Vaporizer (GE Medical) – Anesthetic Delivery (2024)

Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.

FDANov 18, 2024Nationwide• GE Medical Systems, LLC

Tec 6 Plus Vaporizer (GE Medical) – Anesthetic Delivery (2024)

Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.

FDANov 18, 2024Nationwide• GE Medical Systems, LLC

Discovery MR750w 3.0T Scanner (GE Medical) – acoustic noise risk (2024)

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

FDAOct 28, 2024Nationwide• GE Medical Systems, LLC

SIGNA Architect MRI System (GE Medical) – acoustic noise risk (2024)

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

FDAOct 28, 2024Nationwide• GE Medical Systems, LLC

Tomographic Imager (GE Medical) – acoustic noise risk (2024)

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

FDAOct 28, 2024Nationwide• GE Medical Systems, LLC

SIGNA Architect AIR MRI (GE Medical) – acoustic noise risk (2024)

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

FDAOct 28, 2024Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: SIGNA MR355, with affected software versions: SV25.5, SV...

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

FDAJun 14, 2024Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: SIGNA PET/MR, with affected software versions: MP24.0, M...

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

FDAJun 14, 2024Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: SIGNA Pioneer, with affected software versions: PX25.0 t...

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

FDAJun 14, 2024Nationwide• GE Medical Systems, LLC