Z-2475-2018Class II

SOMATOM Perspective 16 (Model 10891666)

Name: Z-2475-2018 SOMATOM Perspective 16 (Model 10891666)
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-02-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-02-01 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Perspective 16 (Model 10891666) on 2018-02-01. FDA classified it as Class II and gives the reason as "A potential risk of unnecessary radiation exposure due to a software issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2475-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-01
Posted: 2018-03-30
Terminated: 2020-05-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Perspective 16 (Model 10891666)
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A potential risk of unnecessary radiation exposure due to a software issue
Root cause tag: software
FDA root cause: Software design
Action: Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2475-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2472-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28
Z-2473-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28
Z-2474-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28
Z-2475-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28
Z-2476-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28
Z-2477-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28
Z-2478-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28

Product code JAK

K113287Class IISomatom PerspectiveSiemens Medical Solutions USA, Inc. / cleared 2012-05-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)