Z-1933-2025Class II

Intera 1.5T Master/Nova Product Number: 781106

Name: Z-1933-2025 Intera 1.5T Master/Nova Product Number: 781106
Creator: Philips North America
Published: 2025-05-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2025-05-29 / Open, Classified / root cause: manufacturing process

FDA source

Philips North America began a recall of Intera 1.5T Master/Nova Product Number: 781106 on 2025-05-29. FDA classified it as Class II and gives the reason as "identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1933-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-29
Posted: 2025-06-09
Recalling firm: Philips North America LLC
Product: Intera 1.5T Master/Nova Product Number: 781106;
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On May 30, 2025 UPDATE - URGENT MEDICAL DEVICE CORRECTION LETTERS were sent to customers. 4.Actions that should be taken by the customer / user in order to prevent risks for patients or users 4.1. When using any affected system identified according to the information in section 3, followthe instructions below. 4.2. Pay particular attention if a scan interruption occurs and a scan abort symbol is encountered, which may appear in the user interface (UI) with the symbols shown in Figure 4 below: Figure 4. Scan Abort Symbols 4.3. When scan aborts occur the symbol is shown and applicable messages are presented in the message box (see Figure 5 and Figure 6 examples) 4.3.1. Check the status of the error messages in the User Interface (UI) screen. Click to expand the message box in case previous messages are hidden, see orange box in Figure 5 and Figure 6 below. If possible, correct the issue that is relevant to the error shown and continue scanning, for example: " RF door must be closed while performing scan. Scan aborted. " Patient support is moved while scanning, scan stopped. " Coil A (or B) failure, coil disconnected? . Figure 5. UI example SW Version R11. Figure 6. UI example SW Version R5. 4.3.2. If, after a scan abort, one of the following conditions occur five times in a row stop scanning immediately and contact Philips Service to describe the problem: "If there is no error message in the message box "If the error message meaning is not clear 4.3.3. If the error message Gradient amplifier Rack Fault is received two times in a row, or if the error message Gradient amplifier Rack Fault is preceded or followed by an aborted scan with no message, then stop scanning immediately and contact Philips Service to describe the problem. 4.3.4. If you encounter any of these conditions described in 4.3.2 or 4.3.3 do not attempt any additional/further scans, including without limitation do not attempt any phantom scanning until your system has been checked and released b
Quantity in commerce: 2 units (US only)
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.
Product codes and lots: Product Number: 781106; UDI-DI: no UDI; Serial Numbers: 8009, 18863;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1933-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1928-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-09
Z-1929-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-09
Z-1930-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-09
Z-1931-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-09
Z-1932-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-09
Z-1933-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-09
Z-1934-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-09
Z-1935-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-09
Z-1936-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-09

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)