Z-1879-2019 Class III Terminated
FDA device recall Z-1879-2019 was initiated by GE Healthcare, LLC on May 10, 2019 and is designated Class III. 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. The recall status is terminated (terminated May 24, 2024). Affected quantity: 58,045 units (31,108 US; 26937 OUS) in total.
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
Reason for Recall
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.