Device recall: ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems)…

Class II FDA enforcement event 68529. Recall start date: 3 Jun 2014. Status in the FDA record: Terminated. Termination date: 25 May 2016.

Reason for recall, in the words of FDA

There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.

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 3 Jun 2014. The firm address in the FDA record is in Mountain View, CA. FDA put the recall in Class II. FDA event 68529 has 1 product record. The first FDA enforcement report date is 9 Jul 2014. The record gives the status Terminated, with the termination date 25 May 2016.

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 - USA including CA, MO, VA, PA, WV, and Internationally to Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Czech Republic,…

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 68529: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1962-2014	ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.	790 units	Class II	Terminated	9 Jul 2014

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 2014: 1,176
Share of these events in Class II: 91%
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-1962-2014The 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 68529. https://recallregister.com/fda/ii/68529/. 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 - USA including CA, MO, VA, PA, WV, and Internationally to Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Czech Republic,…
What quantity of product is in FDA event 68529?: The FDA record gives this quantity: 790 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2014 have the same class?: 91% of the 1,176 device events that started in 2014 are in Class II.