Recall Z-2523-2018— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2016-09-16, terminated 2018-07-26. It names one FDA 510(k) clearance: K103448. Product: Brivo XR385, model 5215463, Digital Diagnostic Radiographic System. Reason: 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..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-16
- Terminated
- 2018-07-26
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.