Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
Reported: August 1, 2018 Initiated: September 16, 2016 #Z-2523-2018
Product Description
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
Reason for Recall
The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 58 (55 US, 3 OUS)
- Distribution
- AK, AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MS, NJ, NM, OR, PA, TN, TX, VA, and Guam, and Canada.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System. Recalled by GE Healthcare, LLC. Units affected: 58 (55 US, 3 OUS).
Why was this product recalled? ▼
The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 1, 2018. Severity: Moderate. Recall number: Z-2523-2018.
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