Ingenia 1.5T CX recallZ-0392-2024 · Philips North America Llc · initiated Oct 23, 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 Llc 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
Potential component failure in the Gradient Coil could product smoke and/or fire.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm mailed URGENT Medical Device Correction Notices dated 10/23/2023 to consignees to notify them of this recall event. Consignees are instructed to identify if they possess any affected devices in their inventory and to follow the provided instructions for when scan aborts occur to prevent the failure mode associated with this recall event. Consignees are to stop the scan immediately and contact Philips Service if any of the failure situations outlined in the notice occur during a scan. Consignees are asked to complete and return the provided response form to Philips no later than 30 days after receipt of the recall notice. Questions can be directed to Customer Care Solutions at 1-800-722-9377.
Recall details
- Recall number
- Z-0392-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 23, 2023
- Posted by the FDA
- Nov 21, 2023
- Recalling firm
- Philips North America Llc
- Quantity
- 48 units
- Product code
- LNH
- FDA submissions
- K063559, K162931, K052013, K052078, K173079
- Distribution
- Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.
Product description
Ingenia 1.5T CX
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
Product No. 781261 & 781262; UDI-DI: (01)00884838068438(21)77008, (01)00884838068438(21)77016, (01)00884838068438(21)77018, (01)00884838068445(21)77032, (01)00884838068445(21)77034, (01)00884838068445(21)77035, (01)00884838068445(21)77038, (01)00884838068445(21)77040, (01)00884838068445(21)77041, (01)00884838068445(21)77046, (01)00884838068445(21)77049, (01)00884838068445(21)77050, (01)00884838068445(21)77054, (01)00884838068445(21)77056, (01)00884838068445(21)77058, (01)00884838068445(21)77059, (01)00884838068445(21)77061, (01)00884838068445(21)77062, (01)00884838068445(21)77065, (01)00884838068445(21)77066, (01)00884838068445(21)77067, (01)00884838068445(21)77071, (01)00884838068445(21)77072, (01)00884838068445(21)77074, (01)00884838068445(21)77075, (01)00884838068445(21)77078, (01)00884838068445(21)77081, (01)00884838068445(21)77083, (01)00884838068445(21)77084, (01)00884838068445(21)77087, (01)00884838068445(21)77093, (01)00884838068445(21)77094, (01)00884838068445(21)77097, (01)00884838068445(21)77100, (01)00884838068445(21)77101, (01)00884838068445(21)77106, (01)00884838068445(21)77109, (01)00884838068445(21)77110, (01)00884838068445(21)77111, (01)00884838068445(21)77119, (01)00884838068445(21)77120, (01)00884838068445(21)77121, (01)00884838068445(21)77124, (01)00884838068445(21)77126, (01)00884838068445(21)77129, (01)00884838068445(21)77130, (01)00884838068445(21)77131, (01)00884838068445(21)77137; Serial No. 77008, 77016, 77018, 77032, 77034, 77035, 77038, 77040, 77041, 77046, 77049, 77050, 77054, 77056, 77058, 77059, 77061, 77062, 77065, 77066, 77067, 77071, 77072, 77074, 77075, 77078, 77081, 77083, 77084, 77087, 77093, 77094, 77097, 77100, 77101, 77106, 77109, 77110, 77111, 77119, 77120, 77121, 77124, 77126, 77129, 77130, 77131, 77137.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ingenia 1.5T CX 781262Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance spectroscopic8 recalls9 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93361).
- Z-0389-2024 · Open, ClassifiedAchieva 1.5T
- Z-0395-2024 · Open, ClassifiedSmartPath to dStream for 1.5T
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.
How recalls are matched to devices · Editorial policy · Report an error on this page