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.
FDA Recall Z-1005-2011 · Posted 2011-02-01
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2009-10-02
Date Terminated2011-03-29
Product Quantity67 units total
Reason for Recall
ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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