CLASS II Device recall · Reported 29 Jun 2016 · FDA Enforcement Report

Biograph 64 - 3 Ring, Material Number 08727450 The Siemens recalled

Siemens Medical Solutions USA is recalling Biograph 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are, distributed nationwide in the US. The recall was initiated on 22 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 1001,1002,1003,1004,1007,1010,1012,1013,1014,1015,1016,1017,1018,1019,1022

Quantity recalled15 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-2013-2016
FDA event ID: 74192
Recalling firm: Siemens Medical Solutions USA, Knoxville, TN
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2016
FDA classified: 21 Jun 2016
Reported: 29 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

22 Apr 2016	Recall initiated by company
21 Jun 2016	Classified by FDA	+60 days
29 Jun 2016	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

Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

Product as listed by the FDA

BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint 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

Worldwide Distribution - US Nationwide

Nationwide

Questions about this recall

Is Biograph 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are recalled?

Yes. Siemens Medical Solutions USA recalled Biograph 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are on 22 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-2013-2016.

Why was it recalled?

Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

Which lots are affected?

Serial Numbers: 1001,1002,1003,1004,1007,1010,1012,1013,1014,1015,1016,1017,1018,1019,1022

Where was it sold?

Worldwide Distribution - US Nationwide

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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