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.
This recall has been terminated (originally issued April 4, 2011).
- Recall Initiated
- April 7, 2009
- Posted
- April 4, 2011
- Terminated
- April 5, 2011
- Recall Number
- Z-1884-2011
- Quantity
- 61 units
- Firm Location
- Mountain View, CA
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
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
Root Cause
Software design
Action Taken
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.