CardioLab/ComboLab Recording Systems recall
CardioLab/ComboLab Recording Systems
Why was CardioLab/ComboLab Recording Systems recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- CardioLab/ComboLab Recording Systems
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 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.
- Recall date
- November 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)