Z-0893-2022Class II

Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems

Name: Z-0893-2022 Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Creator: Siemens Medical Solutions USA, Inc.
Published: 2022-03-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-03-11 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems on 2022-03-11. FDA classified it as Class II and gives the reason as "There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue". 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-0893-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-11
Posted: 2022-04-07
Terminated: 2023-04-14
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customer Advisory Notice Letter will be provided to each impacted consignee. Depending on the customer s capabilities, Siemens provides the letters via mail, e-mail, or hand delivery by a service engineer. The receipt of the letter will be documented, and additional attempts will be made until such receipt is acknowledged. The safety advisory letter informs customers: You may continue to use your system ensuring to follow all instructions in the Operator Manual. If any changes in system vibrations or noises are detected, then activate the Emergency Stop (E-Stop), discontinue use of the system immediately and contact your service engineer.
Quantity in commerce: 7 devices
Distribution: Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.
Product codes and lots: A) Symbia Intevo Bold system; Model Number 11007962; Serial Numbers: 1) 1499 (UDI:40568690011591499) 2) 1501(UDI: 40568690011591501) 3) 1505 (UDI: 40568690011591505) 4) 1510 (UDI: 40568690011591510) B) Symbia Intevo 6 system; Model Number 10764803; Serial Numbers: 1) 2352 (UDI: 40568690012342352) 2) 2353 (UDI: 40568690012342353) 3) 2354 (UDI: 40568690012342354)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0893-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0893-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-07

Product code KPS

K200474Class IISymbia 6.7Siemens Medical Solutions USA, Inc. / cleared 2020-03-20

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)