Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version 200.0.054, P/N 05936518 and 10037593 , Si
FDA device recall Z-0298-2008 · posted 2008-01-09 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Image error: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.
- Action taken
- The firm sent a recall letter, Urgent Medical Device Notification, to consignees on 07/10/2007, to be followed by a service visit by Siemens personnel for a mandatory software update to be installed. Short term the users were instructed to avoid increasing the SieClear compounding levels to an Advanced SieClear compounding setting after an L/R invert action with Biopsy guidelines on-screen.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 418 units (Z-0297-0298-2008)
- Distribution
- Worldwide: Product was distributed to medical facilities Nationwide including the states of OH, FL, IL, NY, CA, NH, TX, NJ, PA, MD, MO, GA, WA, WI, NE, WV, HI, MA, SC, MI, VA, AZ, UT, NH, RI, KY, SD,
- Date initiated
- 2007-07-10
- Date posted
- 2008-01-09
- Date terminated
- 2010-12-20
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM (K063803) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007-01-05 |