Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1135-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 16, 2023

Date Posted: February 22, 2023

Recall Number: Z-1135-2023

Event ID: 91518

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.

Status: Ongoing

Product Quantity: 6 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated