FDAClass IIFebruary 26, 2020

Luminos dRF Max recall

Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray…

Why was Luminos dRF Max recalled?

Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.

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 5043 5085 5825 5234 5862 5751 5810 5188 5352 5719 5803 5812 5920 5921 5209 5069 5086 5151 5299 5372 5611 5037 5072 5947 5049 5190 5892 5961 5364 5163 5919 5355 5902 5690 5767 5954 5884 5278 5963 5956 5682 5953 5634 5951 5120 5962

Product
Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
46
Distribution
US Nationwide distribution.
Recall date
February 26, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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