Z-2587-2018Class II

CT Goldseal BrightSpeed 16 PWR TIO 2 YR

Name: Z-2587-2018 CT Goldseal BrightSpeed 16 PWR TIO 2 YR
Creator: GE Healthcare, LLC
Published: 2018-05-24
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-05-24 / Terminated

FDA source

GE Healthcare, LLC began a recall of CT Goldseal BrightSpeed 16 PWR TIO 2 YR on 2018-05-24. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2587-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-24
Posted: 2018-07-31
Terminated: 2019-02-08
Recalling firm: GE Healthcare
Product: CT Goldseal BrightSpeed 16 PWR TIO 2 YR
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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).
FDA 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 in commerce: 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.
Product codes and lots: Serial number 194800HM9, System ID Number ALLIANCECT171

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2587-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2578-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-31
Z-2579-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-31
Z-2580-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-31
Z-2581-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-31
Z-2582-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-31
Z-2583-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-31
Z-2584-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-31
Z-2585-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-31
Z-2586-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-31
Z-2587-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-31

Product code JAK

K052855Class IIStarspeed Series CT Scanner SystemsGE Healthcare / cleared 2005-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)