GE Healthcare, Proteus XR/a
Medical device recall Z-1988-2014. 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
- 3460 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, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
3460, 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 00000023354HL4 804289HDFER 00000017868HL1 801268ER 00000024445HL9 804747DHPER 00000018247HL7 972596PER3 00000021176HL3 804541ER 00000018523HL1 408977ER3 00000019915HL8 772468ER1 00000018898HL7 813571ERPRO…
Every code shown here, 1,990 characters
Mfg Lot or Serial # System ID 00000023354HL4 804289HDFER 00000017868HL1 801268ER 00000024445HL9 804747DHPER 00000018247HL7 972596PER3 00000021176HL3 804541ER 00000018523HL1 408977ER3 00000019915HL8 772468ER1 00000018898HL7 813571ERPRO 00000018576HL9 850747GCER 00000024536HL5 904391RAD1 00000019171HL8 561395RAD 00000020749HL8 773282TOMO8 00000034015HL8 847316PROER1 00000012567HL4 502868RAD2 00000017199HL1 972596OPRAD1 00000017648HL7 405271UPX1 00000032656HL1 407518PR1 00000041533HL1 580249SPRO2 00000022569HL8 614868PRO4 00000012718HL3 706257SFP 00000020559HL1 770748PER 00000033658HL6 704783PRO1 00000019846HL5 423493ER 00000031607HL5 605342RAD 00000012703HL5 915573RAD1 00000012705HL0 915573RAD2 00000020034HL5 410392R3 00000022299HL2 706554MSR1 00000003188HL2 901722RAD1 00000019209HL6 718780RAD1 00000011073HL4 865425RAD2 00000018254HL3 281338RAD 00000020919HL7 801292RM3 00000041379HL9 580249SPRO 00000038277HL0 408885SVC 00000029264HL9 561863RM6 00000038416HL4 702382XR1 00000030772HL8 201291PROTEUS 00000018574HL4 201358ER1 00000018682HL5 201358ER2 00000023348HL6 201418RAD1 00000021851HL1 201418RAD3 00000030395HL8 201599PRO 00000100468HL8 201795ER 00000032859HL1 202269PRO 00000013889HL1 202715PRO 00000016974HL8 203679RAD 00000078697HL0 203688PROTLW2 00000021322HL3 203797PROT1 00000022725HL6 203797PROT2 00000028953HL8 203797PROT3 00000027089HL2 203852ED1 00000030390HL9 203852RM1 00000028277HL2 203852RM5 00000023570HL5 205387PRO 00000044402HL6 205750RAD 00000013259HL7 206215RM1 00000037711HL9 206248RAD1 00000034679HL1 206302XRM1 00000013114HL4 206543HECED 00000016238HL8 207454CRAD1 00000080456HL7 207664PROTEUS 00000039888HL3 207795CM3 00000018794HL8 208227RM1 00000019521HL4 208227RM5 00000040501HL9 208265PROT 00000020176HL4 208359RM2 00000020667HL2 208373RAD2 00000023516HL8 208373RAD3 00000019212HL0 208381ED1 00000103408HL1 208402RAD1 00000042856HL5 208455RAD3 00000041973HL9 208455RAD4 00000035259HL1 208463RAD1 00000015447HL6 208463RAD2 00000029208HL6 208476CRAD…
FDA’s list runs to 89,640 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 89,640 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.