Z-2584-2018Class II

Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK

Name: Z-2584-2018 Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK
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 Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK 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-2584-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-24
Posted: 2018-07-31
Terminated: 2019-02-08
Recalling firm: GE Healthcare
Product: Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
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: a. HVY WAUK, Serial Number CJRBX1700130CN (System ID 770836EVO, UDI 01008406821097961117120021CJRBX1700130CN), Serial Number CJRBX1800005CN (System ID 918635REVO, UDI 01008406821097961118010021CJRBX1800005CN); b. LONG HINO, Serial Number RE36A1800042YC (System ID 864560REV1, UDI 01008406821097961118020021RE36A1800042YC), Serial Number RE36A1800036YC (System ID 216448REVO, UDI 01008406821097961118020021RE36A1800036YC); c. LONG WAUK, Serial Number CJRBX1800037CN (System ID 740383REVO, UDI 01008406821097961118040021CJRBX1800037CN), Serial Number CJRBX1800022CN (System ID 317415REVO, UDI 01008406821097961118020021CJRBX1800022CN), Serial Number CJRBX1800013CN (System ID 423844REVO, UDI 01008406821097961118010021CJRBX1800013CN), Serial Number CJRBX1700132CN (System ID 719557REVO, UDI 01008406821097961117120021CJRBX1700132CN), Serial Number CJRBX1800008CN (System ID 510248EVOCT, UDI 01008406821097961118010021CJRBX1800008CN); d. MID BJG, Serial Number 500918HM8 (System ID 918623REVO, UDI Not Available), Serial Number CBCGG1700116HM (System ID 704834EVO, UDI 01008406821097961117120021CBCGG1700116HM), Serial Number CJRBX1800022CN (System ID 864560REVOL, UDI 01008406821097961118020021CJRBX1800022CN), Serial Number CBCGG1700097HM (System ID 979BRENCT1, UDI 01008406821097961117110021CBCGG1700097HM), Serial Number CBCGG1700094HM (System ID 405779REVO, UDI 01008406821097961117110021CBCGG1700094HM), Serial Number CBCGG1700107HM (System ID 217283HREVO, UDI 01008406821097961117110021CBCGG1700107HM), Serial Number CBCGG1700102HM (System ID 303SWDEVO, UDI 01008406821097961117110021CBCGG1700102HM), Serial Number CBCGG1700112HM (System ID 908788EVO, UDI 01008406821097961117120021CBCGG1700112HM), Serial Number 490670HM7 (System ID 718226REVO, UDI Not Available); e. MID WAUK, Serial Number CJRBX1800017CN (System ID 478454EVO, UDI 01008406821097961118020021CJRBX1800017CN), Serial Number CJRBX1800028CN (System ID 210MASHREVO, UDI 01008406821097961118030021CJRBX1800028CN), Serial Number CJRBX1800014CN (System ID 601968REVO, UDI 01008406821097961118010021CJRBX1800014CN).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2584-2018
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

K131576Class IIOptima Ct660Ge Medical Systems, LLC / cleared 2013-08-30

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)