CLASS II Device recall · Reported 17 Apr 2013 · FDA Enforcement Report

Siemens Acuson SC2000 Ultrasound System recalled

Siemens Medical Solutions USA is recalling Siemens Acuson SC2000 Ultrasound System. The recall was initiated on 28 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll units of this model.

Quantity recalled120 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-1081-2013
FDA event ID: 64855
Recalling firm: Siemens Medical Solutions USA, Mountain View, CA
Classification: Class II
Status: Terminated
Recall initiated: 28 Mar 2013
FDA classified: 10 Apr 2013
Reported: 17 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Imaging Equipment

Timeline

28 Mar 2013	Recall initiated by company
10 Apr 2013	Classified by FDA	+13 days
17 Apr 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of the MPI Board. There is a potential to cause esophageal burns in patients.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Where it was distributed

Worldwide Distribution - USA and countries of Australia, Austria, Bosnia Herzegovina, Belgium, Finland, France, Germany, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, P.R. China, Portugal, Rep.of Korea, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan and United Kingdom.

Questions about this recall

Is Siemens Acuson SC2000 Ultrasound System recalled?

Yes. Siemens Medical Solutions USA recalled Siemens Acuson SC2000 Ultrasound System on 28 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-1081-2013.

Why was it recalled?

Which lots are affected?

All units of this model.

Where was it sold?

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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