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U.S. Department of Health and Human Services

Class 2 Device Recall Acuson with Physio Module

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  Class 2 Device Recall Acuson with Physio Module see related information
Date Initiated by Firm October 02, 2009
Date Posting Updated February 01, 2011
Recall Status1 Terminated 3 on March 29, 2011
Recall Number Z-1007-2011
Recall Event ID 53780
510(K)Number K063803  K082142  
Product Classification Diagnostic Ultrasonic Transducer - Product Code ITX
Product 10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA.
Code Information Model 10430054
Recalling Firm/
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View CA 94043
For Additional Information Contact Sheila Pickering
Manufacturer Reason
for Recall
ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
FDA Determined
Cause 2
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ITX and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI