Recall Z-0257-2020— GE Healthcare, LLC

Name: FDA recall Z-0257-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-16

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-09-16, terminated 2020-12-16. It names one FDA 510(k) clearance: K130626. Product: CardioLab/ComboLab Recording Systems. Reason: 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-09-16
Terminated: 2020-12-16
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K130626 — MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYSGe Medical Systems Information Technologies, Inc.·cleared 2013-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CardioLab/ComboLab Recording Systems

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.