Z-2125-2023 Class II Ongoing
FDA device recall Z-2125-2023 was initiated by GE Vingmed Ultrasound As on May 30, 2023 and is designated Class II. Reason for recall: GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations. The recall status is ongoing. Affected quantity: 14 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2023
- Initiation Date
- May 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
GE Healthcare Vivid S70, ultrasound device
Reason for Recall
GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
Distribution Pattern
Worldwide distribution.
Code Information
Software versions: V203, v204