Z-0047-2018Class II

Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia...

Name: Z-0047-2018 Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2017-09-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-09-18 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model... on 2017-09-18. FDA classified it as Class II and gives the reason as "The torque wrench used to tighten system bolts during installation was found to be out of tolerance". 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-0047-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-18
Posted: 2017-10-25
Terminated: 2017-12-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: The torque wrench used to tighten system bolts during installation was found to be out of tolerance
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The recall was initiated via phone and visit beginning 9/18/2017.
Quantity in commerce: 16 devices
Distribution: Distribution was made to medical facilities located in CA, FL, GA, LA, NY, PA, and TN. There was government distribution but no foreign/military distribution.
Product codes and lots: Symbia T2 serial number 2001; Symbia Intevo Excel serial numbers 2112 and 2140; Symbia Intevo 16 serial numbers 2100 and 2116; Symbia Evo serial numbers 1049, 1054, 1071, 1075, 1104, and 1128; and Symbia Evo Excel serial numbers 1109, 1111, 1131, 1134, and 1158.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0047-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0047-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-01	2017-10-25

Product code KPS

K162337Class IISymbia 6.5Siemens Medical Solutions USA, Inc. / cleared 2016-09-08

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)