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Recall Observatory FDA recall evidence

Device product

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

Z-1134-2023

January 16, 2023

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc.
Event
Event 91518
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1134-2023

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: UDI/DI 405686901102894792, Material Number 10532746, Serial Number 94792

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.