FDAClass IIJuly 31, 2019

AXIOM Artis MP recall

AXIOM Artis MP, Model Number 5904466

Why was AXIOM Artis MP 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: 20334 20052 20303 20238 20242 20322 20282 20363 20338 20295 20348 20172 20264 20367 20258 20265 20250 20249 20281 20243 20339 20321 20294 20254

Product
AXIOM Artis MP, Model Number 5904466
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
24
Distribution
US Nationwide Distribution
Recall date
July 31, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls