Recalls / —

—#162935

Product

SOMATOM Perspective 16 (Model 10891666)

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K113287

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2018-02-01

Posted by FDA

2018-03-30

Terminated

2020-05-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #162935. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.