Class 2 Device Recall Ingenia Elition S

• Date Initiated by Firm: June 12, 2023
• Date Posted: August 11, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2396-2023
• Recall Event ID: 92720
• 510(K)Number: K173356 K173451 K183063 K193215 K213516
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
• Code Information: Product Number: 781357: UDI-DI: 00884838088108 Serial Numbers: 46119 46111 46109 46107 46104 46101 46097 46095 46094 46093 46092 46089 46088 46086 46085 46084 46083 46082 46081 46078 46077 46076 46075 46071 46069 46068 46067 46066 46065 46061 46060 46059 46058 46057 46055 46054 46053 46052 46050 46049 46048 46046 46045 46044 46042 46041 46039 46037 46036 46034 46033 46032 46031 46030 46029 46027 46026 46025 46024 46023 46021 46020 46019 46018 46017 46016 46015 46014 46013 46012 46011 46008 46007 46005 46004 46003 46002 46001 46121; Product Number 782106: UDI-DI: 00884838098329 Serial Numbers: 61017 61010 46324 46315 46311 46310 46304 46289 46286 46285 46282 46270 46269 46268 46265 46258 46252 46249 46247 46243 46241 46240 46239 46237 46235 46234 46233 46231 46228 46226 46225 46224 46222 46220 46219 46218 46217 46215 46214 46213 46212 46211 46209 46208 46207 46206 46205 46204 46203 46202 46201 46200 46242 46245 46263 46305 46264 46281 46325; Product Number: 782150: UDI-DI: N/A Serial Numbers: 26003 26010 26006 26001
• Recalling Firm/ Manufacturer: Philips North America; 222 Jacobs St; Cambridge MA 02141-2296
• Manufacturer Reason for Recall: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT Medical Device Correction Notice dated 6/5/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users: 4.1. Philips has installed a SmokeDetector Interlock feature on all the systems listed in Appendix A. Post this notice near the affected MR system(s) for ease of reference. Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm until this issue has been resolved. Please complete and return the attached updated customer response form to Philips promptly and no later than 30 days from receipt of this letter. Philips is requesting that even if you acknowledged a previous version of this letter that you also respond with an acknowledgment to this updated letter. 4.2. The SmokeDetector Interlock feature is integrated with the MR System and powers off the relevant part of the system (Gradient Amplifier) when smoke is detected in order to prevent further development of smoke and/or fire. If the SmokeDetector Interlock has detected smoke and has powered off the Gradient Amplifier: Remove patient from the system according to the instructions for use because power to the tabletop will still be active Scanning is disabled until Philips service has checked the system. Do not attempt to continue scanning. Immediately inform Philips Service DO NOT attempt to restart or perform a power cycle of the system 4.3. If a user experiences smoke, fire, or severe image quality issues (image artifacts caused by electrical disturbances): Immediately stop scanning and evacuate the patient from the Examination Room. Check Examination Room for a developing fire. If a developing fire is sensed, adhere to established fire emergency procedures, which may include switching off power to the complete system and/or removing the magnet field by using the Emergency Magnet Off button Scanning is disabled until Philips service has checked t
• Quantity in Commerce: 640 total
• Distribution: US Nationwide. Global Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LNH; 510(K)s with Product Code = LNH; 510(K)s with Product Code = LNH