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U.S. Department of Health and Human Services

Class 2 Device Recall CardioLab/ComboLab Recording Systems

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  Class 2 Device Recall CardioLab/ComboLab Recording Systems see related information
Date Initiated by Firm September 16, 2019
Create Date October 31, 2019
Recall Status1 Terminated 3 on December 16, 2020
Recall Number Z-0257-2020
Recall Event ID 83899
510(K)Number K130626  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product CardioLab/ComboLab Recording Systems
Code Information Model Number: 2088700-002, No UDI Number, Lot Numbers: RXJ19122006TA, RXJ19122002TA, RXJ19122010TA, RXJ19122001TA, RXJ19122005TA, RXJ19122007TA;   Model Number: 2088700-004, UDI Number (Lot Numbers): 01008406821196031119050021RXJ19204004TA (RXJ19204004TA), 01008406821196031119040021RXJ19154006TA (RXJ19154006TA), 01008406821196031119050021RXJ19224011TA (RXJ19224011TA), 01008406821196031119050021RXJ19224017TA (RXJ19224017TA), 01008406821196031119050021RXJ19224014TA (RXJ19224014TA), 01008406821196031119040021RXJ19154009TA (RXJ19154009TA), 01008406821196031119040021RXJ19154011TA (RXJ19154011TA), 01008406821196031119040021RXJ19154010TA (RXJ19154010TA), 01008406821196031119040021RXJ19154007TA (RXJ19154007TA), 01008406821196031119050021RXJ19194009TA (RXJ19194009TA), 01008406821196031119040021RXJ19154003TA (RXJ19154003TA), Not Available (RXJ19224002TA), 01008406821196031119050021RXJ19224016TA (RXJ19224016TA), 01008406821196031119050021RXJ19204003TA (RXJ19204003TA), 01008406821196031119040021RXJ19154001TA (RXJ19154001TA), 01008406821196031119050021RXJ19194003TA (RXJ19194003TA), 01008406821196031119050021RXJ19224013TA (RXJ19224013TA), 01008406821196031119050021RXJ19194002TA (RXJ19194002TA), 01008406821196031119050021RXJ19194011TA (RXJ19194011TA), 01008406821196031119050021RXJ19204007TA (RXJ19204007TA), 01008406821196031119040021RXJ19154005TA (RXJ19154005TA), 01008406821196031119050021RXJ19204006TA (RXJ19204006TA), 01008406821196031119050021RXJ19194007TA (RXJ19194007TA), 01008406821196031119050021RXJ19194004TA (RXJ19194004TA), 01008406821196031119040021RXJ19154008TA (RXJ19154008TA), 01008406821196031119050021RXJ19204002TA (RXJ19204002TA), 01008406821196031119050021RXJ19224001TA (RXJ19224001TA), 01008406821196031119050021RXJ19194001TA (RXJ19194001TA), 01008406821196031119050021RXJ19224012TA (RXJ19224012TA), 01008406821196031119050021RXJ19194008TA (RXJ19194008TA), 01008406821196031119050021RXJ19194005TA (RXJ19194005TA), 01008406821196031119040021RXJ19154004TA (RXJ19154004TA), 01008406821196031119050021RXJ19194006TA (RXJ19194006TA), 01008406821196031119050021RXJ19224009TA (RXJ19224009TA), 01008406821196031119050021RXJ19204005TA (RXJ19204005TA), 01008406821196031119050021RXJ19194010TA (RXJ19194010TA), 01008406821196031119040021RXJ19154002TA (RXJ19154002TA)
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 Potential for failure of the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab II Plus Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient.
FDA Determined
Cause 2		 Device Design
Action GE Healthcare notified customers of the recall on about 09/16/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that certain CLab II Plus Amplifiers used with CardioLab/ComboLab systems have failed the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab II Plus Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient. Instructions included that customers could continue to use the system by following the below instructions: 1. Test all equipment used in conjunction with CardioLab/ComboLab per manufacturer instructions on electrical safety to ensure that all equipment is in good operating condition and performs per manufacturer specifications. Note: Due to the potential safety risks of other devices used in conjunction with CLab II Plus Amplifiers in Electrophysiology Procedures, all equipment that can electrically contact the patient during a procedure should be checked against each devices safety conformances in manufacturer specifications. 2. If you suspect another connected device is or may be malfunctioning, discontinue use of the CLab II Plus Amplifier until all nonconforming equipment is corrected. If nonconforming equipment is used in conjunction with the CLab II Plus Amplifier, the CLab II Plus Amplifier will not provide necessary mitigation to prevent patient shock. Customers were also informed that GE Healthcare will correct all affected products and a GE Healthcare representative will contact customers to arrange for the correction. They were asked to complete and return the "MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT" form.
Quantity in Commerce 43 (27 US, 16 OUS)
Distribution Nationwide distribution to CA, CT, FL, IN, MD, MI , MN, MO, NC, NE, NJ, OH, PA, TX, WI. International distribution to Canada, France, India, Japan, Korea (Republic Of), Mexico, Spain, Taiwan.
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 = DQK and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
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