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U.S. Department of Health and Human Services

Class 2 Device Recall CLARAVUE

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  Class 2 Device Recall CLARAVUE see related information
Date Initiated by Firm March 15, 2022
Create Date April 14, 2022
Recall Status1 Open3, Classified
Recall Number Z-0939-2022
Recall Event ID 89810
510(K)Number K101685  
Product Classification Electrode, electrocardiograph - Product Code DRX
Product CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US
Model: 32028780 50603-US
Code Information All lots UDI: 03700506307319
Recalling Firm/
Manufacturer		 Graphic Controls Acquisition Corporation
400 Exchange St
Buffalo NY 14204-2064
For Additional Information Contact Peter OLoughlin Vice President, General Manager
716-853-7500
Manufacturer Reason
for Recall		 Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.
FDA Determined
Cause 2		 Device Design
Action Graphic Controls (d/b/a Nissha Medical Technologies/Vermed/Biomedical Innovations) issued Urgent Field Correction letter via email on 3/4/22. Letter states reason for recall, health risk and action to take: Section 5.1.5 of the standard provides that trunk cables and patient leadwires may be permanently marked to indicate they are not defibrillation proof. Immediately examine your inventory and complete the provided form Claravue IP Set Correction Notice Acknowledgement Form and return to claravue@nisshamedical.com If you have product in inventory our team will arrange for it to be returned and exchanged for product labeled correctly once available. In addition, if you may have further distributed this product, please identify your customer and notify them at once of this product correction. Your notification may be enhanced by including a copy of this correction letter. Please complete and return the attached form via e-mail to jpotter@nisshamedical.com as soon as possible. If you have any questions about this notice, please contact: Ms. Jessica Potter, Vice President Quality and Regulatory Nissha Medical Technologies, 400 Exchange Street, Buffalo, NY 14204, USA Phone: (716) 849-6367 E-Mail: jpotter@nisshamedical.com
Distribution US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.
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 = DRX and Original Applicant = INTEGRAL PROCESS SAS
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