CLASS II Device recall · Reported 8 Aug 2018 · FDA Enforcement Report
Revolution EVO 3.6, labeled as recalled by GE Healthcare
GE Healthcare is recalling Revolution EVO 3.6, labeled as a. HVY WAUK, distributed nationwide in the US. The recall was initiated on 24 May 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2584-2018
- FDA event ID
- 80484
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 May 2018
- FDA classified
- 31 Jul 2018
- Reported
- 8 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 24 May 2018 | Recall initiated by company | |
| 31 Jul 2018 | Classified by FDA | +68 days |
| 8 Aug 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
Where it was distributed
Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
Nationwide AlabamaCaliforniaColoradoFloridaIllinoisIndianaMassachusettsMarylandMichiganMississippiNorth CarolinaNew JerseyNew YorkOhioOklahomaSouth CarolinaTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
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).
Where was it sold?
Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 80484This product is part of a recall event; the main page for the event is CT Goldseal Optima CT recalled by GE Healthcare.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CT Goldseal Optima CT recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide | |
| CLASS II | Discovery MI Digital Ready recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide | |
| CLASS II | Discovery IQ 2.0, 4 ring recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide | |
| CLASS II | Optima CT recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide | |
| CLASS II | Optima CT recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide | |
| CLASS II | Revolution CT 160 1.5D STD WAUK recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide | |
| CLASS II | Discovery MI, labeled as Discovery DMI 3 ring recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide | |
| CLASS II | Discovery RT labeled as recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide | |
| CLASS II | CT Goldseal BrightSpeed 16 PWR TIO 2 YR recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
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