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

Biograph mCT-S(64) 4R, Material Number 10248672 The Siemens recalled

Siemens Medical Solutions USA is recalling Biograph mCT-S(64) 4R, Material Number 10248672 The Siemens Biograph TruePoint systems, 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: 1013,11055,1005,1006,1004,1011,1003,1002,1008,1009,1010,11022,11028,1012,1016,1017,1019,11020,1007,11023,11024,11025,11026,11029,11030,11032,11033,11056,1018,11036,1014,11038,11039,11027,11049,11057,11040,11041,11042,11043,11031,11035,11044,11045,11034,11046,11047,11048,11037,11050,11051,11052,11053,11054,11058,11059,11060,11061,11062,11063,11064,11065,11067,11068,11069,11070,11071,11072,11074,11073,11075,11076,11066,11077,1001,11078,11079,11081,11083,11084,11082,11086,11087,11088,11080,11090,11091,11092,11094,11093,11096,21097,11095,21098,11089,21100,31110,21101,21102,21103,21099,21105,31106,11015,21104,31107,31108,31109,31111,31112,31113,31114,31124,31115,31117,31118,31119,31120,31121,90001,31122,31125,31126,1015,31116,31123,31127

Quantity recalled127 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-2033-2016
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 mCT-S(64) 4R, MATERIAL NUMBER 10248672 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

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: 1013,11055,1005,1006,1004,1011,1003,1002,1008,1009,1010,11022,11028,1012,1016,1017,1019,11020,1007,11023,11024,11025,11026,11029,11030,11032,11033,11056,1018,11036,1014,11038,11039,11027,11049,11057,11040,11041,11042,11043,11031,11035,11044,11045,11034,11046,11047,11048,11037,11050,11051,11052,11053,11054,11058,11059,11060,11061,11062,11063,11064,11065,11067,11068,11069,11070,11071,11072,11074,11073,11075,11076,11066,11077,1001,11078,11079,11081,11083,11084,11082,11086,11087,11088,11080,11090,11091,11092,11094,11093,11096,21097,11095,21098,11089,21100,31110,21101,21102,21103,21099,21105,31106,11015,21104,31107,31108,31109,31111,31112,31113,31114,31124,31115,31117,31118,31119,31120,31121,90001,31122,31125,31126,1015,31116,31123,31127

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 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

32 other products · FDA event 74192

This product is part of a recall event; the main page for the event is Biograph mCT Flow 20-4R, Material Number recalled.

Reported	Class	Recall	Company	Reason	Where
29 Jun 2016	CLASS II	Biograph mCT Flow 20-4R, Material Number recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Sys Ivk, Bio mCT-S(40) 3R->4R Upgrade recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph 40 TruePoint w/TrueV recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT-S(64) 3R, Material Number 10248669 The Siemens recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT Flow 64-4R, Material Number recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT Flow 40-3R, Material Number recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph 40-3R to 64-3R Upgrade recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph 6-4R TruePoint w/TrueV recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT S(20)-4R, Material Number 10534160 The Siemens recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT Flow 64-3R, Material Number recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph Sys 40-3R to 40-4R recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph 64-3R TruePoint, Material Number recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph 16 TruePoint, Material Number 10249555 The Siemens recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Sys Ivk, Bio mCT-X 3R->4R Upgrade recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT-X 4R, Material Number 10248670 The Siemens recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph 6 TP 3R to 4R Upgrade recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph Sys 16-3R to 16-4R upgrade recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph 64-4R TruePoint w/TrueV recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT-S(40) 4R, Material Number 10248671 The Siemens recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph 64 - 3 Ring, Material Number 08727450 The Siemens recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph Sys 64-3R to 64-4R recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT-S(40) 3R, Material Number 10248668 The Siemens recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT-X 3R, Material Number 10248673 The Siemens recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph 6 TruePoint, Material Number 10097289 The Siemens recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT Flow Edge-4R, Material Number recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT S(20) - 3R, Material Number recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT Flow 20-3R, Material Number recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT Flow 40-4R, Material Number recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph mCT Flow Edge-3R, Material Number recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph 16 TruePoint TV, Material Number recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph 40 - 3 Ring, Material Number 10097233 The Siemens recalled	Siemens Medical Solutions USA	Other	Nationwide
29 Jun 2016	CLASS II	Biograph 40 TruePoint, Material Number 10097303 The Siemens recalled	Siemens Medical Solutions USA	Other	Nationwide

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