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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenia Elition S

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  Class 2 Device Recall Ingenia Elition S see related information
Date Initiated by Firm June 12, 2023
Date Posted August 11, 2023
Recall Status1 Open3, Classified
Recall Number Z-2399-2023
Recall Event ID 92727
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 4609446093 46092 46089 46088 46086 46085 46084 46083 46082 46081 46078 46077 46076 46075 46071 46069 46068 46067 4606646065 46061 46060 46059 46058 46057 46055 46054 46053 46052 46050 46049 46048 46046 46045 46044 46042 46041 4603946037 46036 46034 46033 46032 46031 46030 46029 46027 46026 46025 46024 46023 46021 46020 46019 46018 46017 4601646015 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 4626846265 46258 46252 46249 46247 46243 46241 46240 46239 46237 46235 46234 46233 46231 46228 46226 46225 46224 4622246220 46219 46218 46217 46215 46214 46213 46212 46211 46209 46208 46207 46206 46205 46204 46203 46202 46201 4620046242 46245 46263 46305 46264 46281
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
Manufacturer Reason
for Recall		 During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.
FDA Determined
Cause 2		 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. ¿ Ifa 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 the s
Quantity in Commerce 601 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 and Original Applicant = Philips Medical Systems Nederland B.V.
510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland BV
510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland, B.V.
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