Z-0392-2024Class II

Ingenia 1.5T CX

Name: Z-0392-2024 Ingenia 1.5T CX
Creator: Philips North America Llc
Published: 2023-10-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-10-23 / Open, Classified

FDA source

Philips North America Llc began a recall of Ingenia 1.5T CX on 2023-10-23. FDA classified it as Class II and gives the reason as "Potential component failure in the Gradient Coil could product smoke and/or fire". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0392-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-23
Posted: 2023-11-21
Recalling firm: Philips North America LLC
Product: Ingenia 1.5T CX
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Potential component failure in the Gradient Coil could product smoke and/or fire.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 48 units
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0392-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0389-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0390-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0391-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0392-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0393-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0394-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0395-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21

Product code LNH

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)