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U.S. Department of Health and Human Services

Class 2 Device Recall WorkMate Claris System, Model H700123

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  Class 2 Device Recall WorkMate Claris System, Model H700123 see related information
Date Initiated by Firm May 05, 2021
Create Date June 14, 2021
Recall Status1 Open3, Classified
Recall Number Z-1853-2021
Recall Event ID 87904
510(K)Number K210392  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
Code Information Serial Numbers: 14399319, 15508962, 18782712, 18855856
Recalling Firm/
Manufacturer		 Abbott Laboratories Inc. (St Jude Medical)
1 Saint Jude Medical Dr
Saint Paul MN 55117-1789
For Additional Information Contact Mr. Justin Paquette
651-756-6293
Manufacturer Reason
for Recall		 Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action Beginning on May 5, 2021, consignees will be notified in person by an Abbott field representative. The letter explained the issue and provided recommendations to reduce the risk to the patient.
Quantity in Commerce 4 units
Distribution US Nationwide distribution in the states of MI, KS, MO, TX.
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 = DQK and Original Applicant = Abbott
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