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Recall Observatory FDA recall evidence

Device product

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

Z-1136-2023

January 16, 2023

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc.
Event
Event 91518
Status
Ongoing
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-1136-2023

Official wording

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

Code information: a) 450: UDI/DI 405686923807410106, Material Number 10749669, Serial Number 10106; b) 600: UDI/DI 405686922450311120, Material Number 10749670, Serial Number 11120; UDI/DI 405686922450311116, Material Number 10749670, Serial Number 11116; c) 600 Edge: UDI/DI 405686918321311068, Material Number 10749672, Serial Number 11068

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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