CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report

Biograph mCT X-4R, System Material Number recalled

Siemens Medical Solutions USA is recalling Biograph mCT X-4R, System Material Number 10248670, distributed in Massachusetts, North Carolina. The recall was initiated on 13 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number: 1003

Quantity recalled8 units total

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-0809-2015
FDA event ID: 69897
Recalling firm: Siemens Medical Solutions USA, Knoxville, TN
Classification: Class II
Status: Terminated
Recall initiated: 13 Nov 2014
FDA classified: 16 Dec 2014
Reported: 24 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

13 Nov 2014	Recall initiated by company
16 Dec 2014	Classified by FDA	+33 days
24 Dec 2014	Published in enforcement report	+8 days

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

Reason for recall

Possibility for system display freeze during CT interventional procedures.

Product as listed by the FDA

Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Where it was distributed

Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.

Massachusetts North Carolina

Questions about this recall

Is Biograph mCT X-4R, System Material Number 10248670 recalled?

Yes. Siemens Medical Solutions USA recalled Biograph mCT X-4R, System Material Number 10248670 on 13 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0809-2015.

Why was it recalled?

Possibility for system display freeze during CT interventional procedures.

Which lots are affected?

Serial Number: 1003

Where was it sold?

Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.

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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