Device recall: Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined…

Class II FDA enforcement event 76127. Recall start date: 13 Dec 2016. Status in the FDA record: Terminated. Termination date: 8 May 2017.

Reason for recall, in the words of FDA

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Siemens Medical Solutions USA Inc. started this device recall on 13 Dec 2016. The firm address in the FDA record is in Knoxville, TN. FDA put the recall in Class II. FDA event 76127 has 11 product records. The first FDA enforcement report date is 18 Jan 2017. The record gives the status Terminated, with the termination date 8 May 2017.

FDA enforcement report The 11 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO…

Recalling firm

Siemens Medical Solutions USA Inc., Knoxville, TN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

11 product records in the event.

FDA event 76127: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0992-2017	Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces…	41 units	Class II	Terminated	18 Jan 2017
Z-0993-2017	Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces…	34 units	Class II	Terminated	18 Jan 2017
Z-0994-2017	Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces…	71 units	Class II	Terminated	18 Jan 2017
Z-0995-2017	Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces…	88 units	Class II	Terminated	18 Jan 2017
Z-0996-2017	Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces…	102 units	Class II	Terminated	18 Jan 2017
Z-0997-2017	Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces…	18 units	Class II	Terminated	18 Jan 2017
Z-0998-2017	Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component…	1 unit	Class II	Terminated	18 Jan 2017
Z-0999-2017	Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component…	1 unit	Class II	Terminated	18 Jan 2017
Z-1000-2017	BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces…	51 units	Class II	Terminated	18 Jan 2017
Z-1001-2017	Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces…	1 unit	Class II	Terminated	18 Jan 2017
Z-1002-2017	Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces…	1 unit	Class II	Terminated	18 Jan 2017

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2016: 1,232
Share of these events in Class II: 91%
Product records in this event: 11Median of the firm: 1
Events of the firm on the register: 400

Other events of the firm

Other FDA enforcement events of Siemens Medical Solutions USA Inc.
Initiated	Product (first record)	Type	Class	Records
8 Jun 2026	ARTIS icono ceiling. Model Number: 11328100.	Device	Class II	1
20 May 2026	ARTIS icono biplane. Model Number: 11327600.	Device	Class II	3
12 Mar 2026	ARTIS Pheno VE30A and VE40A, Model 10849000	Device	Class II	1
10 Mar 2026	ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.	Device	Class II	1
9 Mar 2026	ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system	Device	Class II	2
29 Dec 2025	Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Vers	Device	Class II	2
19 Dec 2025	SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS	Device	Class II	4
5 Dec 2025	LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471	Device	Class II	1
24 Oct 2025	MAMMOMAT Revelation;	Device	Class II	3
1 Oct 2025	MAGNETOM Cima.X Upgrade. Model Number: 11689304.	Device	Class I	1

Siemens Medical Solutions USA Inc.: all 400 events

Official channels

FDA enforcement report Z-0992-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 76127. https://recallregister.com/fda/ii/76127/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO…
What quantity of product is in FDA event 76127?: The event has 11 product records. The first record gives this quantity: 41 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2016 have the same class?: 91% of the 1,232 device events that started in 2016 are in Class II.