—#214190

Product

Intera 1.5T Achieva Nova-Dual Product Number: 781173;

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K193215
Affected lot / code info: Product Number: 781173; UDI-DI: no UDI; Serial Numbers: 13010, 13006, 21501;

Why it was recalled

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 (FDA determination)

Process design

Action the firm took

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

Recalling firm

Firm: Philips North America
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2296

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-05-29
Posted by FDA: 2025-06-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214190. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.