FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: 10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA.
- Recall number
- Z-1007-2011
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- 10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA.
- Status
- Terminated
- Initiated
- 2009-10-02
- Posted
- 2011-02-01
- Terminated
- 2011-03-29
- Reason
- ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 67 units total
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Model 10430054
- 510(k) numbers
- ["K063803","K082142"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 2936884
- Firm city
- Mountain View
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28