Artis Pheno fluoroscopic system may lose video display signals
Siemens Artis Pheno fluoroscopic X-ray systems may lose video signals from the Large Display during procedures. In rare cases, both transceivers could fail, affecting displays in the examination and control rooms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries or hospitalizations. The hazard involves potential loss of video signals on a fluoroscopic display system used during clinical procedures, which constitutes a risk-of-harm scenario per the rubric, with a maximum score of High since no incidents have been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 136 Artis Pheno Interventional Fluoroscopic X-Ray Systems (Model No. 10849000) distributed nationwide and internationally.
The Large Display on the system may lose video signals from one or both of its transceivers. In very rare cases, both transceivers could fail simultaneously, resulting in loss of all video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.
The affected systems are used for interventional fluoroscopic procedures. Facilities and healthcare providers using these systems should contact Siemens Medical Solutions USA, Inc. with their system's serial number to determine if their system is affected and for information about remediation options.
The recalled product
- Product
- Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device
- Affected units
- 136
Distribution
Distributed nationwide across the United States.
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