Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Reported: December 30, 2020 Initiated: November 23, 2020 #Z-0695-2021
Product Description
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Reason for Recall
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 3 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.. Recalled by GE Healthcare, LLC. Units affected: 3 units.
Why was this product recalled? ▼
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2020. Severity: Moderate. Recall number: Z-0695-2021.
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