FDAClass IIAugust 28, 2019

MAGNETOM Prisma magnetic resonance diagnostic devices recall

MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582

Why was MAGNETOM Prisma 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 # 66109 66111 166049 66047 166037 66102 66027 66053 66094 66028 66069 66092 66046 66082 166097 66044 166082

Product
MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
17
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