The Recall Desk
ModerateFDA (Devices)·Z-0298-2021·Announced 2020-11-04

Siemens Artis one Fluoroscopic X-Ray Systems Recalled for Monitor Malfunction

Siemens Medical Solutions is recalling 22 Artis one systems because the examination room monitor may become intermittently dysfunctional, causing display issues.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a monitor malfunction that could impact the usability of the device but does not present an immediate risk of serious injury or death.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 22 Siemens Artis one Fluoroscopic X-Ray Systems (Model 10848600) due to a potential malfunction in the examination room monitor. The monitor may become intermittently dysfunctional, resulting in no display, flickering, or incorrect resolution.

The affected units were distributed nationwide in the United States, including in the states of AL, AR, AZ, CA, FL, IN, LA, MI, MO, NC, NJ, NY, PA, TX, and WA. The specific serial numbers for the recalled units are: 82010, 82038, 82039, 82040, 82044, 82054, 82065, 82066, 82070, 82102, 82105, 82108, 82109, 82205, 82213, 82217, 82267, 82308, 82354, 82355, 82378, and 82383.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and necessary corrective actions.

The recalled product

Product
Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition
Affected units
22

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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