GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-0257-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

CardioLab/ComboLab Recording Systems

Product Classification:

Class II

Date Initiated: September 16, 2019

Date Posted: November 6, 2019

Recall Number: Z-0257-2020

Event ID: 83899

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.

Status: Terminated

Product Quantity: 43 (27 US, 16 OUS)

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)

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated