CLASS II ONGOING Device recall · Reported 22 Feb 2023 · FDA Enforcement Report

Siemens Biograph mCT: a) Flow 64-4R Seismic recalled

Siemens Medical Solutions USA is recalling Siemens Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d), distributed nationwide in the US. The recall was initiated on 16 Jan 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 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

Quantity recalled6 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1135-2023
FDA event ID: 91518
Recalling firm: Siemens Medical Solutions USA, Hoffman Estates, IL
Classification: Class II
Status: Ongoing
Recall initiated: 16 Jan 2023
FDA classified: 13 Feb 2023
Reported: 22 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Jan 2023	Recall initiated by company
13 Feb 2023	Classified by FDA	+28 days
22 Feb 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Is Siemens Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) recalled?

Yes. Siemens Medical Solutions USA recalled Siemens Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) on 16 Jan 2023. The recall is Class II and its status is Ongoing. Recall number Z-1135-2023.

Why was it recalled?

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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