Device recall: ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product…

Class II FDA enforcement event 71116. Recall start date: 11 May 2012. Status in the FDA record: Terminated. Termination date: 6 May 2015.

Reason for recall, in the words of FDA

In some cases, the system is unable to capture a clip or image during a routine scan.

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 11 May 2012. The firm address in the FDA record is in Mountain View, CA. FDA put the recall in Class II. FDA event 71116 has 1 product record. The first FDA enforcement report date is 13 May 2015. The record gives the status Terminated, with the termination date 6 May 2015.

FDA enforcement report The 1 product record

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 the countries of:Angola, Armenia, Australia, Austria, Belgium, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Colombia, Czech Republic, Finland, France,…

Recalling firm

Siemens Medical Solutions USA, Inc., Mountain View, CA.

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

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

Products

1 product record in the event.

FDA event 71116: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1581-2015	ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal,…	186 devices	Class II	Terminated	13 May 2015

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 2012: 823
Share of these events in Class II: 88%
Product records in this event: 1Median 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-1581-2015The 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.

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Cite this page

Recall Register. FDA enforcement event 71116. https://recallregister.com/fda/ii/71116/. 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 the countries of:Angola, Armenia, Australia, Austria, Belgium, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Colombia, Czech Republic, Finland, France,…
What quantity of product is in FDA event 71116?: The FDA record gives this quantity: 186 devices
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 88% of the 823 device events that started in 2012 are in Class II.