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.

Field note

Send feedback

We'll only use this to respond to your feedback.