Z-1875-2019 Class III Terminated
Recalled by GE Healthcare, LLC
— Waukesha, WI
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2019
- Initiation Date
- May 10, 2019
- Termination Date
- May 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58,045 units (31,108 US; 26937 OUS) in total
Product Description
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 Cable, Neonatal, DIN 3-lead, AHA, 3.6 m/12 ft. 2106306-002 ECG Trunk Cable, Neonatal, DIN 3-lead, AHA, 1.2 m/4 ft. 2106306-003 ECG Trunk Cable, Neonatal, DIN 3-lead, IEC, 3.6 m/12 ft. 2106306-004 ECG Trunk Cable, Neonatal, DIN 3-lead, IEC, 1.2 m/4 ft. 2106307-001 ECG Trunk Cable, 6-lead, AHA, 3.6 m/12 ft. 2106307-002 ECG Trunk Cable, 6-lead, AHA, 1.2 m/4 ft. 2106307-003 ECG Trunk Cable, 6-lead, IEC, 3.6 m/12 ft. 2106307-004 ECG Trunk Cable, 6-lead, IEC, 1.2 m/4 ft. 2106308-001 ECG Trunk Cable, 12-lead, AHA, 3.6 m/12 ft. 2106308-002 ECG Trunk Cable, 12-lead, AHA, 1.2 m/4 ft. 2106308-003 ECG Trunk Cable, 12-lead, IEC, 3.6 m/12 ft. 2106308-004 ECG Trunk Cable, 12-lead, IEC, 1.2 m/4 ft. 2106310-001 ECG Trunk Cable, 3/5-lead w/ESU filter, AHA, 3.6 m/12 ft. 2106310-002 ECG Trunk Cable, 3/5-lead w/ESU filter, IEC, 3.6 m/12 ft. 2106311-001 ECG Trunk Cable, 3/5-lead, AHA, 6 m/20 ft. 2106311-002 ECG Trunk Cable, 3/5-lead, IEC, 6 m/20 ft. The reusable ECG trunk cable enables ECG monitoring with GE monitoring equipment requiring rectangular 11-pin connector cable.
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 Pattern
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, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malta, Mauritius, Mexico, Moldova, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Palestine (state of), Panama, Poland, Qatar, Republic of Serbia, Romania, Russia, Saudia Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
Code Information
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