Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
FDA device recall Z-2523-2018 · posted 2018-07-16 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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.
- Action taken
- An Important Electronic Product Radiation Warning letter was sent to consignees beginning 9/16/2016. The letter identified affected product, described the issue, and stated that GE will correct the devices without charge. Questions can be directed to 1-800-437-1171.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- KPR
- Quantity 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.
- Date initiated
- 2016-09-16
- Date posted
- 2018-07-16
- Date terminated
- 2018-07-26
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRIVO XR385 (K103448) | Ge Medical Systems, LLC | 2011-08-12 |