Revolution CT
Reported: July 14, 2021 Initiated: March 19, 2021 #Z-2004-2021
Product Description
Revolution CT
Reason for Recall
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 197 (US = 40; OUS = 157)
- Distribution
- Worldwide distribution - US Nationwide
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Revolution CT. Recalled by GE Healthcare, LLC. Units affected: 197 (US = 40; OUS = 157).
Why was this product recalled? ▼
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 14, 2021. Severity: Moderate. Recall number: Z-2004-2021.
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