FDA recall Z-2471-2021

Siemens Medical Solutions USA, Inc. · Class II · device

Product

ACUSON Juniper Diagnostic Ultrasound System

Reason for recall

Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.

Distribution

Worldwide distribution - U.S. Nationwide distribution in the Puerto Rico and the countries of Bosnia Herzegovina, Canada, Colombia, Germany, Greece, Italy, North Macedonia, Poland, and Slovenia.

Key facts

Status
Terminated
Initiation date
2021-07-12
Report date
2021-09-22
Termination date
2024-10-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Issaquah, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2471-2021