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Recall Observatory FDA recall evidence

Device product

Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.

Z-0481-2016

October 30, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 72742
Status
Terminated
Classification
Class II
Quantity
17
Official record key
device-enforcement:Z-0481-2016

Official wording

Reason: 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.

Code information: Model numbers 10094135, 10094137, 10094141, 10848280, 10848281, 10848282, 10848355. Serial Numbers 123026, 147909, 123031, 103030, 147912, 147910, 147921, 147919, 131005, 121096, 125004, 137551, 121088, 109104, 109105, 109107, and 121085.

Distribution pattern: US Distribution to the states of : IL, WI, MA, FL, AL, TN, ND, OH, TX, CA, NJ and MI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.