Revolution EVO 3.6, labeled as a
Medical device recall Z-2584-2018. Published in FDA’s Enforcement Report on Aug 8, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 8, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 19 states named
- 42 units total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
42 units total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a. HVY WAUK, Serial Number CJRBX1700130CN (System ID 770836EVO, UDI 01008406821097961117120021CJRBX1700130CN), Serial Number CJRBX1800005CN (System ID 918635REVO, UDI 01008406821097961118010021CJRBX1800005CN); b. LONG HINO, Serial Number…
Every code shown here, 1,995 characters
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…
FDA’s list runs to 2,079 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
The states and territories these words name
19 states and territories.
Every one of them
- Alabama
- California
- Colorado
- Florida
- Illinois
- Indiana
- Massachusetts
- Maryland
- Michigan
- Mississippi
- North Carolina
- New Jersey
- New York
- Ohio
- Oklahoma
- South Carolina
- Tennessee
- Texas
- Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 24, 2018.
- FDA classified it on Jul 31, 2018.
- FDA’s Enforcement Report published it on Aug 8, 2018.
- FDA terminated it on Feb 8, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,079 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.