Philips North America: MR Systems Recalled Due to Missing High Voltage Warning Labels

Agency Publication Date: January 25, 2024

Summary

Philips North America has recalled 42 units of various Magnetic Resonance (MR) imaging systems because the Liquid Cooling Cabinet (LCC) may have an incorrect electrical shock warning label. The incorrect labels feature a white caution symbol instead of the required yellow background and are missing the high voltage warning symbol altogether. This recall affects several models including the Achieva 1.5T, Achieva 3.0T, Ingenia Ambition X, Intera 1.5T, and SmartPath systems distributed across several U.S. states and international locations. Consumers should contact the manufacturer for specific guidance on verifying and correcting the labeling on their systems.

Risk

The incorrect or missing warning labels fail to properly alert service personnel to high voltage hazards, creating a direct risk of accidental electrical shock during maintenance or repair of the system's cooling cabinet.

What You Should Do

Identify if your MR system is affected by checking the model and serial numbers on your unit. Affected models include Achieva 1.5T (Models 781178, 781196, 781296), Achieva 3.0T (Model 781177), Ingenia Ambition X (Model 782109), Intera 1.5T (Model 781195), and SmartPath to dStream (Models 781260, 782112).
Locate your specific Serial Number to confirm inclusion in this recall: for Achieva 1.5T, check for serials 20150, 22270, 22095, 21113, 33406, 33547, 32773, 32789, or 32388; for Achieva 3.0T, check for 17043; for Ingenia Ambition X, check for 47785; for Intera 1.5T, check for 18887 or 18972; for SmartPath, check for 21020, 9024, 8657, 21200, 21223, 18948, 32131, 30089, or 20204.
Visually inspect the Liquid Cooling Cabinet (LCC) label; if the caution symbol has a white background instead of yellow or if the high voltage lightning bolt symbol is missing, the unit is incorrectly labeled.
Contact Philips North America or your facility's authorized service provider immediately to arrange for the placement of the correct warning labels.
Ensure all service personnel are notified of the potential electrical hazard until the correct warning labels have been applied to the equipment.
For further information or assistance regarding this recall, contact the FDA's medical device line at 1-888-463-6332.

Your Remedy Options

Other Action

Corrective labeling

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Achieva 1.5T

Model / REF:

781178

781196

781296

Lot Numbers:

Serial Number 20150

Serial Number 22270

Serial Number 22095

Serial Number 21113

Serial Number 33406

Serial Number 33547

Serial Number 32773

Serial Number 32789

Serial Number 32388

Product: Achieva 1.5T Conversion

Model / REF:

781283

Lot Numbers:

Serial Number 39016

Product: Achieva 3.0T

Model / REF:

781177

Lot Numbers:

Serial Number 17043

Product: Ingenia Ambition X

Model / REF:

782109

Lot Numbers:

Serial Number 47785

Product: Intera 1.5T

Model / REF:

781195

Lot Numbers:

Serial Number 18887

Serial Number 18972

Product: SmartPath to dStream for 1.5T

Model / REF:

781260

782112

Lot Numbers:

Serial Number 21020

Serial Number 9024

Serial Number 8657

Serial Number 21200

Serial Number 21223

Serial Number 18948

Serial Number 32131

Serial Number 30089

Serial Number 20204

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93788

Status: Active

Manufacturer: Philips North America

Sold By: Philips North America; authorized medical device distributors

Manufactured In: United States

Units Affected: 6 products (7 US; 16 ROW total)

Distributed To: Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska, Texas

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your MR system is affected by checking the model and serial numbers on your unit. Affected models include Achieva 1.5T (Models 781178, 781196, 781296), Achieva 3.0T (Model 781177), Ingenia Ambition X (Model 782109), Intera 1.5T (Model 781195), and SmartPath to dStream (Models 781260, 782112).

Locate your specific Serial Number to confirm inclusion in this recall: for Achieva 1.5T, check for serials 20150, 22270, 22095, 21113, 33406, 33547, 32773, 32789, or 32388; for Achieva 3.0T, check for 17043; for Ingenia Ambition X, check for 47785; for Intera 1.5T, check for 18887 or 18972; for SmartPath, check for 21020, 9024, 8657, 21200, 21223, 18948, 32131, 30089, or 20204.

Visually inspect the Liquid Cooling Cabinet (LCC) label; if the caution symbol has a white background instead of yellow or if the high voltage lightning bolt symbol is missing, the unit is incorrectly labeled.

Contact Philips North America or your facility's authorized service provider immediately to arrange for the placement of the correct warning labels.

Ensure all service personnel are notified of the potential electrical hazard until the correct warning labels have been applied to the equipment.

For further information or assistance regarding this recall, contact the FDA's medical device line at 1-888-463-6332.

Affected Products

Product: Achieva 1.5T

Model / REF:

781178

781196

781296

Lot Numbers:

Serial Number 20150

Serial Number 22270

Serial Number 22095

Serial Number 21113

Serial Number 33406

Serial Number 33547

Serial Number 32773

Serial Number 32789

Serial Number 32388

Product: Achieva 1.5T Conversion

Model / REF:

781283

Lot Numbers:

Serial Number 39016

Product: Achieva 3.0T

Model / REF:

781177

Lot Numbers:

Serial Number 17043

Product: Ingenia Ambition X

Model / REF:

782109

Lot Numbers:

Serial Number 47785

Product: Intera 1.5T

Model / REF:

781195

Lot Numbers:

Serial Number 18887

Serial Number 18972

Product: SmartPath to dStream for 1.5T

Model / REF:

781260

782112

Lot Numbers:

Serial Number 21020

Serial Number 9024

Serial Number 8657

Serial Number 21200

Serial Number 21223

Serial Number 18948

Serial Number 32131

Serial Number 30089

Serial Number 20204

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93788

Status: Active

Manufacturer: Philips North America

Sold By: Philips North America; authorized medical device distributors

Manufactured In: United States

Units Affected: 6 products (7 US; 16 ROW total)

Distributed To: Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska, Texas