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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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  Class 2 Device Recall Philips see related information
Date Initiated by Firm July 30, 2021
Create Date August 25, 2021
Recall Status1 Open3, Classified
Recall Number Z-2344-2021
Recall Event ID 88461
510(K)Number K173451  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The system can produce cross-sectional images, spectroscopic images
and/or spectra in any orientation of the internal structure of the head, body or extremities
Model Number: 781358
Code Information S/N and UDI: US: 45245 (01)00884838088115(21)45245; 45247 (01)00884838088115(21)45247; 45261 (01)00884838088115(21)45261; 45263 (01)00884838088115(21)45263; 45264 (01)00884838088115(21)45264; 45269 (01)00884838088115(21)45269; OUS: 45215 (01)00884838088115; 45284 (01)00884838088115; 45253 (01)00884838088115; 45313 (01)00884838088115; 45265 (01)00884838088115; 45297 (01)00884838088115; 45218 (01)00884838088115; 45272 (01)00884838088115; 45281 (01)00884838088115; 45231 (01)00884838088115; 45278 (01)00884838088115; 45279 (01)00884838088115; 45245 (01)00884838088115; 45247 (01)00884838088115;
Recalling Firm/
Manufacturer
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer Reason
for Recall
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
FDA Determined
Cause 2
Nonconforming Material/Component
Action Philips North America issued U.S. customers letters via certified mail using a 3rd Party service. Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall , health risk and action to take: The Philips Ingenia 1.5T, Ingenia 1.5T Evolution, Ingenia 3.0T, and Ingenia Elition X MR systems can continue to fulfill clinical use as normal. However, in case of technical problems related to off cooling of the magnet, magnet pressure or Helium boil-off, please stop use and contact your local Philips service representative immediately and reference FCO78100530. A Philips Field Service Engineer (FSE) will contact you to schedule an on-site visit to resolve the issue by inspecting the potentially affected system(s) to confirm if the non-conforming pressure relief (42 psi) has been installed (reference FCO78100530). If your system has a 42 psi valve, the Phillips FSE will replace the valve with the correct 3.75 psi valve. you need any further information or support concerning this issue, please contact the Customer Care Solutions Center 1-800-722-9377 and reference FCO78100530.
Quantity in Commerce 6 units; 12 OUS
Distribution Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia, Spain, Turkey, Ukraine, United Kingdom.
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.
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