Z-0257-2020Class II

CardioLab/ComboLab Recording Systems

Name: Z-0257-2020 CardioLab/ComboLab Recording Systems
Creator: GE Healthcare, LLC
Published: 2019-09-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-09-16 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of CardioLab/ComboLab Recording Systems on 2019-09-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0257-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-16
Posted: 2019-10-31
Terminated: 2020-12-16
Recalling firm: GE Healthcare
Product: CardioLab/ComboLab Recording Systems
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0257-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0257-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-31

Product code DQK

K130626Class IIMac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System; Combolab Hemodynamic and ElectrophysGe Medical Systems Information Technologies, Inc. / cleared 2013-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)