The Recall Desk
HighFDA (Devices)·Z-1311-2023·Announced 2023-04-05

Fluoroscopic X-Ray System Recalled for Unintended Table Movement Risk

Siemens ARTIS pheno X-ray systems may experience unintended table movement that the system fails to detect, risking injury to patients, staff, or operators. The FDA is recalling 141 affected units nationwide.

What this means for you

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: FDA Class II medical device with risk-of-harm (unintended table movement causing potential injury to patients and staff), but no reported injuries or hospitalizations. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

The FDA is recalling ARTIS pheno fluoroscopic X-ray systems manufactured by Siemens Medical Solutions USA, Inc. The recall affects 141 units distributed nationwide in the United States. These systems may be equipped with either a Siemens Healthineers table or a Trumpf/MAQUET table.

The recalled systems may experience unintended table movement and may fail to detect that the table is moving in an incorrect direction. When this occurs, it could result in injury to patients, staff members, operators, or damage to equipment.

The recall applies to units with UDI #4056869046877 and specific serial numbers identified in the FDA notification. Facilities operating these systems should verify whether their equipment is included by checking the serial number against the recall list.

The recalled product

Product
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Imaging Equipment
Hazard
  • unintended-table-movement
  • detection-failure
  • injury-risk

Distribution

Distributed nationwide across the United States.

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