FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
- Recall number
- Z-0761-2013
- Recalling firm
- GE Healthcare, LLC
- Product
- GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
- Status
- Terminated
- Initiated
- 2012-08-03
- Posted
- 2013-02-26
- Terminated
- 2013-12-05
- Reason
- GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE Healthcare will, without charge, remedy the issue or bring the product into compliance with each applicable Federal and IEC standard in accordance with a planto be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the software on the system to address the issue. Contact Call Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification
- Quantity
- 9 units installed in US
- Distribution
- Nationwide Distribution including NM, WY, FL, MO, MA, and MI.
- Lot, serial or model codes
- Model Number : 5271997
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAC
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28