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Terminated

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.

FDA Recall Z-1006-2011 · Posted 2011-02-01

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYO
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.

K082142ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008-11-13K063803ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007-01-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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