GE Healthcare, Revolution XR/d
Medical device recall Z-1989-2014. Published in FDA’s Enforcement Report on Jul 9, 2014.
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 Jul 9, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 3 states named in where it went
- 1053 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?
GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
1053, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # System ID 00000000001837 815338WXRD 00000000002821 815759RAD2 00000000003407 205206SWXRD1 00000000001153 205838AXRD1 00000000003535 205939SVER 00000000002574 209669XRD 00000000001745 215481DR19 00000000001320 215481DR21…
Every code shown here, 1,990 characters
Mfg Lot or Serial # System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…
FDA’s list runs to 27,410 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.
Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGRY, ICELAND, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM YEMEN.
The states and territories these words name
- District of Columbia
- Guam
- Puerto Rico
They leave out Vermont.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Jun 4, 2014.
- FDA classified it on Jul 2, 2014.
- FDA’s Enforcement Report published it on Jul 9, 2014.
- FDA terminated it on May 6, 2015.
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 27,410 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
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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.