Reported Nov 6, 2019 · Terminated
CardioLab/ComboLab Recording Systems
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- CardioLab/ComboLab Recording Systems
- Lot codes and dates
- Model Number2088700-002, No UDI Number
- Lot Numbers
RXJ19122006TARXJ19122002TARXJ19122010TARXJ19122001TARXJ19122005TARXJ19122007TA
- Model Number2088700-004
- 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)
- Amount recalled
- 43 (27 US, 16 OUS)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new GE Healthcare, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.