Skip to content
Recall Observatory FDA recall evidence

Device product

SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile

Z-1135-2023

January 16, 2023

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc.
Event
Event 91518
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-1135-2023

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) Flow 64-4R Seismic, UDI/DI 405686900142560047, Material Number 10529161, Serial Number 60047; b) S(40)-3R Seismic, UDI/DI 405686900131960054, Material Number 10248668, Serial Number 60054; c) S(64)-3R Seismic, UDI/DI 405686900133360091, Material Number 10248669, Serial Number 60091; d) S(40)-4R Seismic, UDI/DI 405686900132660047, Material Number 10248671, Serial Number 60047; e) S(64)-4R Seismic, UDI/DI 405686900134060076, Material Number 10248672, Serial Number 60076; f) S(20)-3R Mobile, UDI/DI 405686900129660028, , Material Number 10534159, Serial Number 60028

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.