Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0893-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems

Product Classification:

Class II

Date Initiated: March 11, 2022

Date Posted: April 13, 2022

Recall Number: Z-0893-2022

Event ID: 89790

Reason for Recall:

There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.

Status: Terminated

Product Quantity: 7 devices

Code Information:

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)

Distribution Pattern:

Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated