Syngo Imaging XS model number 10496279 The intended use: image processing radiological
FDA device recall Z-1423-2010 · posted 2010-04-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- images can be overwritten
- Action taken
- A "Customer (Safety) Advisory notice" dated February 16, 2010, was sent all affected customers via Update Instructions IM019/10/S. This notice describes the product, problem and the action to be taken by the customers. The customers should immediately instruct their employees of the advisor notice and maintain awareness. If the customer sold the device/equipment and is no longer in possession of it, they should forward the notice and inform Siemens of the new owner. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instructions IM020/10/S. If you have any further questions regarding this issue, do not hesitate to contact your local SIEMENS Uptime Service Center (michael.mib.braun@siemens.com).
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 6 units
- Distribution
- Nationwide distribution: CA, NC, NY, PA, and TX
- Date initiated
- 2010-02-16
- Date posted
- 2010-04-20
- Date terminated
- 2012-07-05
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO IMAGING XS (K082430) | Siemens AG Medical Solutions | 2008-11-14 |