FDAClass IIAugust 8, 2018

SOMATOM Perspective 16 recall: Software Issue

SOMATOM Perspective 16 (Model 10891666)

Why was SOMATOM Perspective 16 recalled?

A potential risk of unnecessary radiation exposure due to a software issue

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 No. 87559 87579 87532 87539 87563 87565 87560 87555 87556 87553 87554 87526 87567 87561 87589 87569 87535 87525 87548 87541 87558 87533 87537 87522 87542 87534 87549 87546 87584 87574 87552 87600 87577 87571 87528 87540 87594 87544

Product
SOMATOM Perspective 16 (Model 10891666)
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
N/A
Distribution
Nationwide
Recall date
August 8, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls