Acuson Cypress Echocardiography System
FDA device recall Z-0744-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Siemans Medial Solutions USA, Inc
- Reason for recall
- software problem - mode does not appear on screen
- Action taken
- The recalling firm telephoned their direct accounts to inform them of the problem and the need to modify the software. The call were made from 2/2-16/04. The modification kits were sent to consignees via express delivery.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 46 units
- Distribution
- The product was shipped to physicians and medical facilities in AZ, CA, CT, FL, IA, IL, NE, NV, NY, OH, TX, and WA. The product was also shipped to Australia, Brazil, Canada, Denmark, Germany, Italy,
- Date initiated
- 2004-02-02
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-19
- Location
- Plymouth Meeting, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYPRESS ULTRASOUND SYSTEM (K021497) | Acuson Corp. | 2002-07-09 |