FDAClass IIJuly 26, 2017

Artis zee recall

Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…

Why was Artis zee recalled?

Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.

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: 124081 124061 137662 137668 137391 148001 147871 154827 154847 153197 131101 154035

Product
Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
97 distributed worldwide, 12 distributed in United States
Distribution
Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY
Recall date
July 26, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls