Lower risk Medical device recall · FDA · Published January 16, 2023

Siemens Biograph mCT Seismic Scanners: Potential Gantry Locking Issue

Siemens recalls specific Biograph mCT models due to potential gantry locking mechanism failure. Affected units may not secure properly during scanning or service, risking equipment damage or safety issues.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1135-2023Medical device Siemens ›

Lower-risk 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.

Take action

Contact the company

Recalling firmSiemens Medical Solutions USA, Inc.2501 Barrington Rd · Hoffman Estates, IL 60192-2061

✎ GovInfoNow plain-language explainer

Siemens is recalling several Biograph mCT MRI scanners because their gantry locking mechanism might not secure properly during scanning or service. This could lead to equipment damage or safety risks if the scanner moves unexpectedly. Read more at govinfonow.com/recall/59031-siemens-biograph-mct-seismic-scanners-potential-gantry-locking-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/59031-siemens-biograph-mct-seismic-scanners-potential-gantry-locking-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1135-2023

Cite this page

“Siemens Biograph mCT Seismic Scanners: Potential Gantry Locking Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59031-siemens-biograph-mct-seismic-scanners-potential-gantry-locking-issue. Based on FDA recall #Z-1135-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1135-2023%22&limit=1).

The FDA announced on Jan. 16, 2023, that Siemens Medical Solutions USA, Inc. is recalling six SIEMENS Biograph mCT units due to a potential locking mechanism failure. The agency classified the recall as Class II.

How to tell if you have it

Brand: Siemens
Product: SIEMENS Biograph mCT
Models: Flow 64-4R Seismic, S(40)-3R Seismic, S(64)-3R Seismic, S(40)-4R Seismic, S(64)-4R Seismic, S(20)-3R Mobile
Quantity: 6 units

The hazard

According to the FDA, the recall addresses a potential problem with the locking mechanism used to secure the PET gantry in either its scanning or service position.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), Siemens ARTIS icono ceiling recall (May 20, 2026), and Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026).

How to tell if you have this one

Check for the model names: Flow 64-4R Seismic, S(40)-3R Seismic, S(64)-3R Seismic, S(40)-4R Seismic, S(64)-4R Seismic, or S(20)-3R Mobile. Look for specific serial numbers and material numbers listed in the recall notice.

Brand
Siemens
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.

Recall number	Product, codes & lots	Quantity
Z-1134-2023	SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission; UDI/DI 405686901102894792, Material Number 10532746, Serial Number 94792	1 unit
Z-1135-2023	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; 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	6 units
Z-1136-2023	SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge; a) 450: UDI/DI 405686923807410106, Material Number 10749669, Serial Number 10106; b) 600: UDI/DI 405686922450311120, Material Number 10749670, Serial Number 11120; UDI/DI 405686922450311116, Material Number 10749670, Serial Number 11116; c) 600 Edge: UDI/DI 405686918321311068, Material Number 10749672, Serial Number 11068	4 units

Based on the official FDA remedy

What to do — step by step

Check Model and Serial Numbers
Identify the model and serial number from the scanner's label to confirm if it's affected by this recall.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 37 days after the firm started it.

Jan 16, 2023Firm started the recall
Feb 13, 2023FDA classified it Class II
Feb 22, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Siemens recalls

Link to this recall

<a href="https://govinfonow.com/recall/59031-siemens-biograph-mct-seismic-scanners-potential-gantry-locking-issue">Siemens Biograph mCT Seismic Scanners: Potential Gantry Locking Issue (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1135-2023 (January 16, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1135-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.