FDAClass IIJuly 31, 2019

Artis zee floor MN recall

Artis zee floor MN, Model Number 10094142

Why was Artis zee floor MN recalled?

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

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: 140212 140115 140101 140205 140213 140204 140209 140219 140224 140218 140221 140220 140206 140223 140105 140226 140108 140102 140109 140100 140202 140214 140114

Product
Artis zee floor MN, Model Number 10094142
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
23
Distribution
US Nationwide Distribution
Recall date
July 31, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls