INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Reported: September 7, 2022 Initiated: January 31, 2022 #Z-1666-2022
Product Description
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Reason for Recall
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Details
- Recalling Firm
- Canon Medical System, USA, INC.
- Units Affected
- 16 systems
- Distribution
- US Nationwide Distribution
- Location
- Tustin, CA
Frequently Asked Questions
What product was recalled? ▼
INFX-8000V. For radiographic and fluoroscopic studies and intervention.. Recalled by Canon Medical System, USA, INC.. Units affected: 16 systems.
Why was this product recalled? ▼
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2022. Severity: Moderate. Recall number: Z-1666-2022.
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