Acuson Cypress Echocardiography System. Imaging System
FDA device recall Z-0975-03 · posted 2003-07-02 · Terminated
Recall details
- Recalling firm
- Siemans Medial Solutions USA, Inc
- Reason for recall
- software problem - loss of data
- Action taken
- The recalling firm issued a letter dated 4/03 explaining the problem and the work around. A software upgarde is being provided free of charge to the customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 1540 units
- Distribution
- The device was shipped to hospitals and physicians nationwide. The device was also shipped to accounts in Argentina, Australia, Austria, Belgium, Boliva, Brazil, Canada, Chile, Columbia, Costa Rica, C
- Date initiated
- 2003-04-01
- Date posted
- 2003-07-02
- Date terminated
- 2004-01-16
- Location
- Plymouth Meeting, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYPRESS ULTRASOUND SYSTEM (K021497) | Acuson Corp. | 2002-07-09 |