Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall WorkMate Claris System, Model H700123

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall WorkMate Claris System, Model H700123see related information
Date Initiated by FirmMay 05, 2021
Create DateJune 14, 2021
Recall Status1 Terminated 3 on June 18, 2024
Recall NumberZ-1853-2021
Recall Event ID 87904
510(K)NumberK210392 
Product Classification Computer, diagnostic, programmable - Product Code DQK
Productv.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 ContactMr. 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
ActionBeginning 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 Commerce4 units
DistributionUS Nationwide distribution in the states of MI, KS, MO, TX.
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 = DQK
-
-