EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Reported: November 7, 2018 Initiated: October 5, 2018 #Z-0372-2019
Product Description
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Reason for Recall
The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc.
- Units Affected
- 264 units
- Distribution
- Worldwide
- Location
- Hoffman Estates, IL
Frequently Asked Questions
What product was recalled? ▼
EVO Excel, Emission Computed Tomographic System, Material Number 10910501. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 264 units.
Why was this product recalled? ▼
The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 7, 2018. Severity: Moderate. Recall number: Z-0372-2019.
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