FDA-Device2017-11-01Class II
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.
Siemens Medical Solutions USA, Inc.
Hazard
The torque wrench used to tighten system bolts during installation was found to be out of tolerance
Sold states
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.
Affected count
16 devices
Manufactured in
2501 Barrington Rd, N/A, Hoffman Estates, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0047-2018Don't want to check this manually?
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