ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2106305-004 ECG Trunk Cable, 3/5-lead, IEC, 1.2 m/4 ft. 2106306-001 ECG Trunk Cab
Check against the official notice below — it lists the full affected range.
GE Healthcare, LLC is recalling ECG trunk cables and leadwires with catalog numbers 2106305-001, 2106305-002, 2106305-003, 2106306-001, 2106306-002, 2106306-003, 2106307-001, 2106307-002, 2106307-003, 2106308-001, 2106308-002, 2106310-001, and 2106311-001. The cables may reduce the amount of energy reaching a patient during defibrillation, potentially limiting the success of defibrillating the patient's heart rhythm. Approximately 58,045 units have been distributed worldwide, including 31,108 units in the United States and territories, and 26,937 units in other countries.
The recalled products do not have lot or serial numbers, so identification depends on the catalog and reference numbers listed above. The source document does not specify what consumers or healthcare providers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
Reason for recall: ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm. Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Quantity: 58,045 units (31,108 US; 26937 OUS) in total Lot/code info: Product does not have lot or serial numbers REF/Catalog Number GTIN/UDI 2106305-001 00840682137775 2106305-002 00840682137898 2106305-003 none 2106305-004 none 2106306-001 00840682137843 2106306-002 00840682137737 2106306-003 none 2106306-004 none 2106307-001 00840682137836 2106307-002 00840682137751 2106307-003 none 2106307-004 none 2106308-001 00840682137713 2106308-002 00840682137812 2106308-003 none 2106308-004 none 2106310-001 00840682137935 2106310-002 none 2106311-001 00840682137676 2106311-002 none
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.