FDA recall Z-2127-2023

GE Vingmed Ultrasound As · Class II · device

Product

GE Healthcare Vivid S70N, 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

Worldwide distribution.

Key facts

Status: Ongoing
Initiation date: 2023-05-30
Report date: 2023-07-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Horten, N/A, Norway

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2127-2023