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.
Reported: November 1, 2017 Initiated: September 18, 2017 #Z-0047-2018
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.
Reason for Recall
The torque wrench used to tighten system bolts during installation was found to be out of tolerance
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc.
- Units Affected
- 16 devices
- Distribution
- 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.
- Location
- Hoffman Estates, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 16 devices.
Why was this product recalled? ▼
The torque wrench used to tighten system bolts during installation was found to be out of tolerance
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 1, 2017. Severity: Moderate. Recall number: Z-0047-2018.
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