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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 CLARAVUEsee related information
Date Initiated by FirmMarch 15, 2022
Create DateApril 14, 2022
Recall Status1 Terminated 3 on July 12, 2024
Recall NumberZ-0936-2022
Recall Event ID 89810
510(K)NumberK101685 
Product Classification Electrode, electrocardiograph - Product Code DRX
ProductCLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
Code Information All lots UDI: 03700506307340
Recalling Firm/
Manufacturer		 Graphic Controls Acquisition Corporation
400 Exchange St
Buffalo NY 14204-2064
For Additional Information ContactPeter 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
ActionGraphic 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
Quantity in Commerce560 units
DistributionUS Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DRX
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