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U.S. Department of Health and Human Services

Class 2 Device Recall Acuson Antares PE

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 Class 2 Recall
Acuson Antares PE
see related information
Date Posted February 01, 2011
Recall Status1 Terminated on March 29, 2011
Recall Number Z-1005-2011
Recall Event ID 53780
Premarket Notification
510(K) Numbers
K063803  K082142 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product 10032746 Acuson Antares PE Product Version 5.0, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for Abdominal, Intraoperative, Small Parts, Transcranial, OB/Gyn, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications.
Code Information Model number 10032746
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94043
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Sheila Pickering
650-694-5993
Manufacturer Reason
for Recall
ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm's Customer Safety Advisory notice was mailed to all affected customers. The letter describes when the malfunction occurs and the potential risk. It also recommended that users collect corresponding evidence with spectral waveforms that would confirm or deny findings based on ECG, in order to avoid potential risks for misdiagnosis. The firm planned to exchange the faulty hardware component in the system. Customers would be contacted to schedule for the hardware exchange. Questions regarding this issue should be directed to the local service support person.
Quantity in Commerce 67 units total
Distribution Worldwide Distribution
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 = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
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