SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer
FDA device recall Z-1645-2015 · posted 2015-05-22 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.
- Action taken
- Siemens sent an Customer Safety Advisory Notice dated April 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A remote software update is scheduled for release that will resolve the issue. For further questions, please call (610) 219-6300.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 75
- Distribution
- Nationwide Distribution including Puerto Rico.
- Date initiated
- 2015-04-20
- Date posted
- 2015-05-22
- Date terminated
- 2016-09-01
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 (K133424) | Siemens Medical Solutions USA, Inc. | 2014-01-17 |