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Terminated

CardioLab/ComboLab Recording Systems

FDA Recall Z-0257-2020 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeDQK
Date Initiated2019-09-16
Date Terminated2020-12-16
Product Quantity43 (27 US, 16 OUS)

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.

Firm 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.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130626MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYSGe Medical Systems Information Technologies, Inc. · 2013-05-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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