CLASS II Device recall · Reported 7 Dec 2016 · FDA Enforcement Report

Z6Ms transesophageal transducers used on Acuson SC2000 recalled

Siemens Medical Solutions USA is recalling Z6Ms transesophageal transducers used on Acuson SC2000 ultrasound systems, Z6Ms, distributed nationwide in the US. The recall was initiated on 7 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel number 10436113 -Z6Ms Transesophageal tranducer. US Serial numbers: 63229007 63229008 63432010 63530518 63322007 63230009 63260584 63530516 63432007 63319012 63332004 63325007 63328003 63328007 63332002 63029015 63329017 63230003. Foreign serial numbers: 63260585 63230002 63029009 63329018 63229011 63432015 63229012 63430524 63029016 63360611 63360612 63432017.

Quantity recalled33

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-0667-2017
FDA event ID: 75639
Recalling firm: Siemens Medical Solutions USA, Mountain View, CA
Classification: Class II
Status: Terminated
Recall initiated: 7 Nov 2016
FDA classified: 28 Nov 2016
Reported: 7 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Imaging Equipment

Timeline

7 Nov 2016	Recall initiated by company
28 Nov 2016	Classified by FDA	+21 days
7 Dec 2016	Published in enforcement report	+9 days

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

Reason for recall

Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.

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

Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Neurological-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 adjunctive with other medical data obtained by a physician for clinical diagnosis purposes.

Where it was distributed

Worldwide Distribution - US (nationwide) Internationally to AUSTRIA, GERMANY, SOUTH AFRICA, NETHERLANDS, MAURITIUS, MEXICO, and ITALY, JAPAN, SWEDEN

Nationwide

Questions about this recall

Is Z6Ms transesophageal transducers used on Acuson SC2000 ultrasound systems, Z6Ms recalled?

Yes. Siemens Medical Solutions USA recalled Z6Ms transesophageal transducers used on Acuson SC2000 ultrasound systems, Z6Ms on 7 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0667-2017.

Why was it recalled?

Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.

Which lots are affected?

Model number 10436113 -Z6Ms Transesophageal tranducer. US Serial numbers: 63229007 63229008 63432010 63530518 63322007 63230009 63260584 63530516 63432007 63319012 63332004 63325007 63328003 63328007 63332002 63029015 63329017 63230003. Foreign serial numbers: 63260585 63230002 63029009 63329018 63229011 63432015 63229012 63430524 63029016 63360611 63360612 63432017.

Where was it sold?

Worldwide Distribution - US (nationwide) Internationally to AUSTRIA, GERMANY, SOUTH AFRICA, NETHERLANDS, MAURITIUS, MEXICO, and ITALY, JAPAN, SWEDEN

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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