Ingenia recallZ-0812-2024 · Philips North America · initiated Dec 29, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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).
Recall details
- Recall number
- Z-0812-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 29, 2023
- Posted by the FDA
- Jan 25, 2024
- Recalling firm
- Philips North America
- Quantity
- 7 US; 16 ROW total
- Product code
- LNH
- FDA submissions
- K193215
- 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 description
SmartPath to dStream for 1.5T, Model No. 781260, 782112
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Ingenia Smartpath to dStream for 1.5TPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance spectroscopic10 recalls131 reports
- Ingenia, Achevia, MR 5300 SmartPath to dStream for 1.5TPhilips Medical Systems Nederland B.V. · System, Nuclear Magnetic Resonance Imaging9 recalls81 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93788).
- Z-0810-2024 · Open, ClassifiedIngenia Ambition X, Model No. 782109
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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