Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
Reported: December 30, 2015 Initiated: October 30, 2015 #Z-0481-2016
Product Description
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
Reason for Recall
Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 17
- Distribution
- US Distribution to the states of : IL, WI, MA, FL, AL, TN, ND, OH, TX, CA, NJ and MI.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 17.
Why was this product recalled? ▼
Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2015. Severity: Moderate. Recall number: Z-0481-2016.
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