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U.S. Department of Health and Human Services

Class 2 Device Recall TEE Transducer V5M

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 Class 2 Recall
TEE Transducer V5M
see related information
Date Posted April 04, 2011
Recall Status1 Terminated on April 05, 2011
Recall Number Z-1884-2011
Recall Event ID 52820
Premarket Notification
510(K) Numbers
K072786  K082142 
Product Classification System, Imaging, Pulsed Echo, Ultrasonic - Product Code IYO
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.
Code Information 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
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94043
For Additional Information Contact Christine Dunbar
650-694-5993
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
510(K)s with Product Code = IYO and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
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