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Siemens Medical Solutions USA, Inc. recalls Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 m
Recalled November 1, 2017 · FDA recall Z-0047-2018 · Siemens Medical Solutions USA
Hazard
The torque wrench used to tighten system bolts during installation was found to be out of tolerance · FDA Class II
Units
16 devices
Sold at
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.
Description
The torque wrench used to tighten system bolts during installation was found to be out of tolerance
Product
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →