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Z-1135-2023 Class II Ongoing

Recalled by Siemens Medical Solutions USA, Inc. — Hoffman Estates, IL

FDA device recall Z-1135-2023 was initiated by Siemens Medical Solutions USA, Inc. on January 16, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 6 units.

Recall Details

Product Type: Devices
Report Date: February 22, 2023
Initiation Date: January 16, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6 units

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

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.

Distribution Pattern

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

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