Z-0812-2024Class III

SmartPath to dStream for 1.5T, Model No. 781260, 782112

Name: Z-0812-2024 SmartPath to dStream for 1.5T, Model No. 781260, 782112
Creator: Philips North America
Published: 2023-12-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-12-29 / Open, Classified / root cause: labeling and UDI

FDA source

Philips North America began a recall of SmartPath to dStream for 1.5T, Model No. 781260, 782112 on 2023-12-29. FDA classified it as Class III and gives the reason as "An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0812-2024
Classification: Class III
Status: Open, Classified
Initiated: 2023-12-29
Posted: 2024-01-25
Recalling firm: Philips North America LLC
Product: SmartPath to dStream for 1.5T, Model No. 781260, 782112
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On December 29, 2023, the firm notified affected customers with URGENT Medical Device Correction letters. The firm stated there is no impact to patients or users. There is a potential risk of electrical shock for service personnel. Customers may continue to use MR systems in accordance with the intended use. Circulate this notice to all users of this device so that they are aware of the issue, and post the letter in the technical room until the electrical shock warning label is updated. A Philips representative will contact you to schedule a time for a Field Service Engineer to verify the electrical shock warning label and apply the correct label if applicable. If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in commerce: 7 US; 16 ROW total
Distribution: Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
Product codes and lots: Model No. 781260 UDI-DI 00884838095076 Serial Numbers 21020 9024 8657 21200 21223 18948 32131; Model No. 782112 UDI-DI 00884838098886 Serial Numbers 30089 20204

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0812-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0807-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-25
Z-0808-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-25
Z-0809-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-25
Z-0810-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-25
Z-0811-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-25
Z-0812-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-25

Product code LNH

K193215Class IIAchieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. / cleared 2020-04-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)