Z-2435-2015Class II

Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear...

Name: Z-2435-2015 Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2015-07-31
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-07-31 / Terminated

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used... on 2015-07-31. FDA classified it as Class II and gives the reason as "Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2435-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-31
Posted: 2015-08-20
Terminated: 2016-12-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.
FDA root cause: Component change control
Action: Siemens has sent an undated Customer Advisory Notice letter to all direct accounts (customers). The letters include instructions for customers to: 1) Continue to use the system(s) while waiting for the field correction to be scheduled and performed unless the user observes a burning smell or sees evidenve of smoke. the user should engage the emergency stop, power down and discontinue use of the system, and contact the local service representative. 2) Ensure that this advisory is placed in the system's instructions for use. Siemens reminds the user to observe the patient during studies. 3) If the product was sold to another party, forward the letter to the party. A local service engineer will contact the customer to schedule the servicing of the affected units by September 2015 which will consist of replacing the affected fuse with the correct amperage rating fuse. If you have any questions regarding the important notice, please contact your local service representative by calling 1-800-888-7436. Europe, Middle East and Africa: +49 9131 940 4000. Asia and Australia: +86 (21) 3811 2121.
Quantity in commerce: 1183 Systems
Distribution: Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and Internationally to Algeria, Argentina , Australia , Austria , Bangladesh , Belgium , Brazil , Bulgaria , Canada , Chile , China, Colombia , Costa Rica , Croatia , Czech Republic , Denmark , Ecuador , Egypt , Estonia, Finland , France , Germany , Hong Kong , Hungary , Iceland , India , Indonesia , Iran , Ireland , Israel , Italy , Japan , Jordan , Kazakhstan , Korea, Kuwait , Latvia , Libya , Lithuania , Luxembourg , Malaysia , Mexico , Morocco , Myanmar , Netherlands , New Zealand , Norway , Oman , Pakistan , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia, Saudi Arabia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania, Thailand , Tunisia , Turkey , United Arab Emirates , Ukraine , United Kingdom , Venezuela , Vietnam
Product codes and lots: Model number 8717741.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2435-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2435-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20
Z-2436-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20
Z-2437-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20

Product code KPS

K142006Class IISymbia 6.0Siemens Medical Solutions USA, Inc. / cleared 2014-08-21

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)