FDAClass IIJuly 31, 2019

AXIOM Artis dMP recall

AXIOM Artis dMP, Model Number 7555365

Why was AXIOM Artis dMP 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: 57204 57089 57077 57024 57144 57189 57208 57035 57188 57073 57072 57016 57009 57050 57207 57111 57171 57113 57193 57008 57198 57155 57124 57004 57105 57098 57116 57045 57156 58701 57183 57187

Product
AXIOM Artis dMP, Model Number 7555365
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
32
Distribution
US Nationwide Distribution
Recall date
July 31, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls