Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Reported: July 7, 2021 Initiated: June 14, 2021 #Z-1900-2021
Product Description
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Reason for Recall
Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 3665
- Distribution
- 3,665 (US = 956; OUS = 2,709)
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Revolution EVO, Optima CT660, Optima CT680 CT Systems.. Recalled by GE Healthcare, LLC. Units affected: 3665.
Why was this product recalled? ▼
Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 7, 2021. Severity: Moderate. Recall number: Z-1900-2021.
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