Recall Z-0270-2010 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression.
| Date | Nov 16, 2009 (initiated Sep 29, 2009) |
| Status | Terminated |
| Reason | Distorted image. The "Distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another source. |
| Root cause | Software design |
| Action | The recalling firm issued a Customer Safety Advisory notice dated 9/14/09 to all affected customers via Update Instructions IM100/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. To avoid the potential risk of the issue, the local compression function can be disabled as described in the letter. Depending on the image data, the disabling of compression will result in increased storage usage. The issue will be resolved in the release of version VA70B. For all potentially affected customers with "JPEG Compression" license an update i |
| Quantity | 28 units |
| Distribution | The product was shipped to medical facilities in CA, FL, GA, IL, MD, MI, MO, NE, NC, NY, OH, PA, TN, TX, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082430 | SYNGO IMAGING XS Siemens AG Medical Solutions, Nov 14, 2008 |