FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Proteus XR/a (SlOK : K993090)
- Recall number
- Z-2449-2019
- Recalling firm
- GE Healthcare, LLC
- Product
- Proteus XR/a (SlOK : K993090)
- Status
- Open, Classified
- Initiated
- 2019-08-09
- Posted
- 2019-09-20
- Terminated
- not on file
- Reason
- Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
- Root cause
- Device Design
- Action
- GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to 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 representative will contact you to arrange for the correction . If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1- 800-437-1171or your local Service Representative.
- Quantity
- 647 US; 167 OUS
- Distribution
- Worldwide - US Nationwide
- Lot, serial or model codes
- console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)
- 510(k) numbers
- ["K993090"]
- PMA numbers
- not on file
- Product code
- KPR
- 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