CLASS II Device recall · Reported 12 Aug 2015 · FDA Enforcement Report

Biograph mCT S(64)-4R recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Biograph mCT S(64)-4R, distributed in Texas. The recall was initiated on 14 Jul 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSERIAL NUMBER 11026

Quantity recalled1 unit

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-2332-2015
FDA event ID: 71712
Recalling firm: Siemens Medical Solutions USA, Knoxville, TN
Classification: Class II
Status: Terminated
Recall initiated: 14 Jul 2015
FDA classified: 5 Aug 2015
Reported: 12 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Jul 2015	Recall initiated by company
5 Aug 2015	Classified by FDA	+22 days
12 Aug 2015	Published in enforcement report	+7 days

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

Reason for recall

Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.

Product as listed by the FDA

Biograph mCT S(64)-4R, Model Number 10248672

Where it was distributed

Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.

Texas

Questions about this recall

Why was it recalled?

Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.

Which lots are affected?

SERIAL NUMBER 11026

Where was it sold?

Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.

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

Other products in this recall event

7 other products · FDA event 71712

This product is part of a recall event; the main page for the event is Biograph 64-3R TruePoint w/ TrueV recalled.

Reported	Class	Recall	Company	Reason	Where
12 Aug 2015	CLASS II	Biograph 64-3R TruePoint w/ TrueV recalled	Siemens Medical Solutions USA	Other	TX
12 Aug 2015	CLASS II	Biograph 6-4R TruePoint w/ TrueV recalled	Siemens Medical Solutions USA	Other	TX
12 Aug 2015	CLASS II	Biograph 64-4R TruePoint w/ TrueV recalled	Siemens Medical Solutions USA	Other	TX
12 Aug 2015	CLASS II	Biograph mCT S(40)-4R recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	TX
12 Aug 2015	CLASS II	SYS IVK, Bio mCT-S(40) 3R->4R recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	TX
12 Aug 2015	CLASS II	Biograph mCT Flow Edge-4R recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	TX
12 Aug 2015	CLASS II	Biograph mCT X-4R recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	TX

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
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8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

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