Recalls / —

—#86506

Product

10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA.

FDA product code

ITX — Transducer, Ultrasonic, Diagnostic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K063803, K082142

Affected lot / code info

Model 10430054

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 #86506. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.