FDAClass IIJuly 10, 2019

Siemens Artis zeego--Interventional Fluoroscopic X-Ray recall

Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959

Why was Siemens Artis zeego--Interventional Fluoroscopic X-Ray 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: 160335 160430 160368 160469 160357 160370 160369 160509 160427 160433 160443 160428 160429 160463 160001 160461 160486 160800 160487 160488 160507 160840 160862 160856 160823 160914 160930 161235 160401

Product
Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
29
Distribution
Nationwide
Recall date
July 10, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls