Z-1884-2011

TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15A or...

Name: Z-1884-2011 TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15A or...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2009-04-07
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-04-07 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15A or VA15B; Model Numbers: 10041461 (Acuson S2000) and... on 2009-04-07. The reason FDA records is "Device function failure--When performing a TEE exam with the transducer, CW (Continuous Wave) mode is not functional. Due to work flow, this may not be apparent until the transducer is inserted into the patient's...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1884-2011
Status: Terminated
Initiated: 2009-04-07
Posted: 2011-04-04
Terminated: 2011-04-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15A or VA15B; Model Numbers: 10041461 (Acuson S2000) and 8263703 (V5M Transducer); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Mountain View, CA Product is a medical device, a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. tis function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, MMode, Pulsed(PW) Doppler mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or harmonic imaging and 3d/4d imaging on a flat panel display. The device system is intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides 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. The device is a multi frequency, multi plane, phased sector array transducer. In the TEE (transesophageal echocardiography process where the device fails, the transducer is introduced into the esophagus of the patient to obtain images of the heart structure.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: Device function failure--When performing a TEE exam with the transducer, CW (Continuous Wave) mode is not functional. Due to work flow, this may not be apparent until the transducer is inserted into the patient's esophagus.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Customer Safety Advisory Notification letter on April 7, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the notice on to all those within their organization who need to be aware of the issue until the corrective action is completed. For questions regarding this recall call 650-969-9112.
Quantity in commerce: 61 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Great Britain, Hong Kong, Indonesia, India, Italy, South Korea, Norway, Turkmenistan, and Taiwan
Product codes and lots: Serial Numbers: 200190, 200191, 200281, 200287, 200366, 200481, 200519, 200577, 200699, 200738, 200759, 200761, 200830, 200836, 200851, 200855, 200857, 200874, 200878, 200925, 201002, 200909, 200966, 200220, 200187, 200218, 200663, 200524, 200395, 200291, 200850, 200854, 200875, 200965, 200178, 200103, 200104, 200118, 200143, 200183, 200200, 200210, 200686, 200694, 200852, 200889, 200908, 200927, 201005, 200849, 200834, 200835, 200839, 200211, 200696, 200859, 200926, 200660, 200661, 200687, 200719

Product code IYO

K082142Class IIAcuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI / cleared 2008-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)