—#86505

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.

FDA product code: IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K063803, K082142
Affected lot / code info: Model number 10041461

Why it was recalled

ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebird Way P.O. Box 7393, Mountain View, California 94043

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2009-10-02
Posted by FDA: 2011-02-01
Terminated: 2011-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86505. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.