FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: CT Goldseal BrightSpeed 16 PWR TIO 2 YR
- Recall number
- Z-2587-2018
- Recalling firm
- GE Healthcare, LLC
- Product
- CT Goldseal BrightSpeed 16 PWR TIO 2 YR
- Status
- Terminated
- Initiated
- 2018-05-24
- Posted
- not on file
- Terminated
- 2019-02-08
- Reason
- Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- Root cause
- Component change control
- Action
- GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
- Quantity
- 42 units total
- Distribution
- Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
- Lot, serial or model codes
- Serial number 194800HM9, System ID Number ALLIANCECT171
- 510(k) numbers
- ["K052855"]
- PMA numbers
- not on file
- Product code
- JAK
- 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