PlainRecalls
FDA Devices Moderate Class II Ongoing

SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge

Reported: February 22, 2023 Initiated: January 16, 2023 #Z-1136-2023

Product Description

SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge

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.

Details

Units Affected
4 units
Distribution
Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.
Location
Hoffman Estates, IL

Frequently Asked Questions

What product was recalled?
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 4 units.
Why was this product recalled?
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 22, 2023. Severity: Moderate. Recall number: Z-1136-2023.