10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA.
FDA device recall Z-1007-2011 · posted 2011-02-01 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
- Action taken
- 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
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 67 units total
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-10-02
- Date posted
- 2011-02-01
- Date terminated
- 2011-03-29
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM (K082142) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-11-13 |
| ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM (K063803) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007-01-05 |