FDA recall Z-1134-2023

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

Product

SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission

Reason for recall

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

Distribution

Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.

Key facts

Status
Ongoing
Initiation date
2023-01-16
Report date
2023-02-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hoffman Estates, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1134-2023