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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Ingenia Elition S, Ingenia Elition X

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  Class 2 Device Recall Philips Ingenia Elition S, Ingenia Elition X see related information
Date Initiated by Firm December 03, 2018
Create Date January 08, 2019
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-0694-2019
Recall Event ID 81797
510(K)Number K173356  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Ingenia Elition S, Ingenia Elition X
Code Information Software version R5.5.0  Serial numbers: 45027 45011 45010 45024 45032 45026 45054 45035 45051 45052 45007 45043 45044 45031 45039 45025 46001 45033 45050 45034 45049 45037 45048 46004 45046 45008 45058 45028 45029 45030 45042 46005 46011 45040 45045 
Recalling Firm/
Manufacturer		 Philips Medical Systems Nederlands
Veenpluis 4-6
Best Netherlands
Manufacturer Reason
for Recall		 During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.
FDA Determined
Cause 2		 Under Investigation by firm
Action On December 4, 2018, the firm notified customers of the recall via an Urgent Medical Device Correction letter. The letter informed customers of the product issue. Customers were asked to do the following: The user must follow the Instructions for Use to verify that no part of the patient's body, hair, clothing, cables or infusion lines can get trapped or injured by any part of the equipment. Additionally, the VitalScreen shows positioning guidance regarding arm supports and padding. The user should avoid the use of the yellow Stop Table button on the VitalScreen. The user must always use the tumble switch or physical Emergency Table Stop button for cases which require the table movement to stop. Philips stated they would be rolling out FCO78100490 Service Pack 1 for R5.5.0 to affected systems. The Service Pack will remove the "Stop Table" software button on the VitalScreen.
Quantity in Commerce 35
Distribution CA, MN, NJ, NY, OH, TN, TX. Foreign distribution to Canada, Belgium, France, Germany, INdia, Japna, Netherlands, South Africa, Sweden, Switzerland, UAE.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland B.V.
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