The Recall Desk
HighFDA (Devices)·Z-0200-2022·Announced 2021-11-10

Artis zeego X-Ray System Software Error Affects Image Reconstruction

Siemens Artis zeego fluoroscopic X-ray systems have a software error that incorrectly displays 3D image reconstruction when the patient table is rotated more than 4 degrees, potentially resulting in incorrect patient treatment during image-guided procedures.

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: This is an FDA Class II recall involving a medical imaging device where a software error creates risk of patient harm. Although no illnesses or injuries have been reported, the software error can directly result in incorrect patient treatment due to misaligned 3D image reconstruction. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling specific models of the Artis zeego fluoroscopic X-ray system (models 10280959, 10502505, 10848283) combined with specific versions of syngo X Workplace software (models 10281061, 10281299, 10502522, and 10848815). Approximately 43 units have been distributed nationwide in the US.

The recalled systems contain a software error that incorrectly interprets patient table rotation. When the patient table has been rotated by more than 4 degrees in either direction, the software produces an incorrect interpretation of the table position. This causes the 3D image reconstruction to be displayed rotated by up to 5 degrees relative to the patient's actual anatomy, creating a spatial misalignment between the image and the patient.

Because the 3D image reconstruction is displayed in incorrect orientation, it can be used inappropriately by the system and medical professionals relying on the imaging data. This misuse of inaccurate spatial information can result in incorrect treatment of the patient during procedures that depend on accurate image-guided intervention.

The recalled product

Product
Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Fluoroscopic X-Ray System
Hazard
  • software-error
  • imaging-error
  • treatment-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Artis zeego systems with Artis patient table and AppSW VD20C/VD20N

Distribution

Distributed nationwide across the United States.

Related recalls

Same category