FDAClass IIAugust 28, 2019

MAGNETOM Skyra magnetic resonance diagnostic devices recall

MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915

Why was MAGNETOM Skyra magnetic resonance diagnostic devices recalled?

Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.

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 # 46066 45732 46182 45735 45805 46171 45693 45886 45988 45881 46144 46044 46176 46179 46032 46238 145161 46127 45774 45968 46196 46175 45681 46007 46021 46105 46142 45928 45815 46150 145302 45878 46239 46026 145403 45667 145536 45970 45839 45982 46145 46298 45777 46294

Product
MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
44
Distribution
AL AR AZ CA CO CT DC DE FL GA GU IA ID IL IN KS KY LA MA MD ME MI MN MO MT NC NE NH NJ NY OH OK OR PA SC TN TX VA WA WI WV WY
Recall date
August 28, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls