Z-0919-2017Class II

SOMATOM Scope, Computed tomography x-ray system

Name: Z-0919-2017 SOMATOM Scope, Computed tomography x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-11-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-11-22 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Scope, Computed tomography x-ray system on 2016-11-22. FDA classified it as Class II and gives the reason as "Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0919-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Posted: 2017-06-21
Terminated: 2017-05-30
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Scope, Computed tomography x-ray system
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens mailed on December 01, 2016 a Customer Safety Notice to affected customers to inform them of a corrective action that is being performed to prevent a possible hazard to persons and equipment. The notice explained the underlying issue, the effect the issue has on the system, the associated risks and actions they will take to correct the issue. In addition, customers will receive a Customer Safety Notice via Hand Delivery from the Siemens Customer Service Engineer at the scheduled appointment for the corrective installation.
Quantity in commerce: 13 systems
Distribution: Distributed to: IL IL GA SC SD OK NY MI IN MD AR
Product codes and lots: Model # 10967666 Serial Number:59376 91766 91767 115456 115454 59380 77560 98840 77557 91758 59377 59378 115451

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0919-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0919-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0920-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0921-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23

Product code JAK

K151749Class IIsomatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)Siemens Medical Solutions USA, Inc. / cleared 2016-03-18

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)