Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Reported: September 28, 2016 Initiated: August 5, 2016 #Z-2852-2016
Product Description
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Reason for Recall
Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 338 systems
- Distribution
- Distributed Nationwide
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 338 systems.
Why was this product recalled? ▼
Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 28, 2016. Severity: Moderate. Recall number: Z-2852-2016.
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