FDAClass IIJuly 10, 2019

Siemens Artis Q.zen biplane-Interventional Fluoroscopic recall

Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355

Why was Siemens Artis Q.zen biplane-Interventional Fluoroscopic recalled?

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: 123049 123216 123046 123236 123211 123202 123043 123219 123240 123230 123246

Product
Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
11
Distribution
Nationwide
Recall date
July 10, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls