FDAClass IIOctober 8, 2014

Siemens AXIOM Luminos dRF Max systems The Axiom Luminos recall

Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and…

Why was Siemens AXIOM Luminos dRF Max systems The Axiom Luminos recalled?

Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images

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?

Siemens AXIOM Luminos dRF Max system material #s: 10762471 with serial number: 5037.

Product
Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
1
Distribution
Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.
Recall date
October 8, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls