GE Healthcare Recalls CardioLab Recording Systems Due to Electrical Shock Risk
GE Healthcare is recalling 43 CardioLab/ComboLab Recording Systems because a failure in connected devices could cause electrical shock to patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of electrical shock (injury) without reported fatalities or hospitalizations, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 43 units of CardioLab/ComboLab Recording Systems (Models 2088700-002 and 2088700-004). The recall involves 27 units in the United States and 16 units internationally. The affected units were distributed nationwide to specific US states and to Canada, France, India, Japan, Korea, Mexico, Spain, and Taiwan.
The recall is due to a potential failure of the patient leakage current test. If another device with electrical connectivity, such as an ablation device or ECG monitor, fails, the CLab II Plus Amplifier may not prevent an electric current from completing a circuit. This malfunction could result in an electrical shock to a patient.
Healthcare facilities and consumers should identify affected units by checking the model numbers and specific lot numbers listed in the official recall notice. No specific instructions for consumer action are provided in the source text beyond the identification of the defect.
The recalled product
- Product
- CardioLab/ComboLab Recording Systems
- Manufacturer
- GE Healthcare, LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: 2088700-002
- No UDI Number
- Lot Numbers: RXJ19122006TA
- RXJ19122002TA
- RXJ19122010TA
- RXJ19122001TA
- RXJ19122005TA
- RXJ19122007TA
- Model Number: 2088700-004
- 01008406821196031119040021RXJ19154006TA (RXJ19154006TA)
- 01008406821196031119050021RXJ19224011TA (RXJ19224011TA)
- 01008406821196031119050021RXJ19224017TA (RXJ19224017TA)
- 01008406821196031119050021RXJ19224014TA (RXJ19224014TA)
- 01008406821196031119040021RXJ19154009TA (RXJ19154009TA)
- 01008406821196031119040021RXJ19154011TA (RXJ19154011TA)
- 01008406821196031119040021RXJ19154010TA (RXJ19154010TA)
- 01008406821196031119040021RXJ19154007TA (RXJ19154007TA)
- 01008406821196031119050021RXJ19194009TA (RXJ19194009TA)
- 01008406821196031119040021RXJ19154003TA (RXJ19154003TA)
- Not Available (RXJ19224002TA)
Distribution
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