| Class 2 Device Recall ACUSON S2000 | |
Date Initiated by Firm | October 02, 2009 |
Date Posted | February 01, 2011 |
Recall Status1 |
Terminated 3 on March 29, 2011 |
Recall Number | Z-1006-2011 |
Recall Event ID |
53780 |
510(K)Number | K063803 K082142 |
Product Classification |
Ultrasonic Pulsed Echo Imaging System - Product Code IYO
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Product | 10041461 ACUSON S2000, manufactured by Siemens Medical Solutions, Mountain View, CA.
Intended for Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/Gyn, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. |
Code Information |
Model number 10041461 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc. 1230 Shorebird Way P.O. Box 7393 Mountain View CA 94043
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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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYO
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