Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0047-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 18, 2017

Date Posted: November 1, 2017

Recall Number: Z-0047-2018

Event ID: 78086

Reason for Recall:

The torque wrench used to tighten system bolts during installation was found to be out of tolerance

Status: Terminated

Product Quantity: 16 devices

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated