GE Healthcare, Proteus XR/a with wall stand
Medical device recall Z-0954-2015. Published in FDA’s Enforcement Report on Jan 21, 2015.
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 Jan 21, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 3096 (2486 US, 610 OUS). 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 recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
3096 (2486 US, 610 OUS)., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
FMI 17107 - Proteus Wall Stand Counterpoise Cables Break Serial # System ID 00000044028HL9 928656ER 00000063303HL2 719595ORTHO 00000045940HL4 803751PR2 00000041478HL9 812238FPCRAD 00000057994HL6 208359PROT 00000046527HL8 310732TIPRO…
Every code shown here, 1,999 characters
FMI 17107 - Proteus Wall Stand Counterpoise Cables Break Serial # System ID 00000044028HL9 928656ER 00000063303HL2 719595ORTHO 00000045940HL4 803751PR2 00000041478HL9 812238FPCRAD 00000057994HL6 208359PROT 00000046527HL8 310732TIPRO 00000047064HL1 318255PRO 00000036130HL3 319352PROT 00000053610HL2 336765WFBIRAD 00000021190HL4 360457ORTHO 00000037481HL9 405377PRO 00000031767HL7 406638CATOMO 00000034159HL4 407628PRO 00000031902HL0 409938TC1 00000074625HL5 419578RAD2 00000096491HL6 419636RAD 00000096684HL6 435563RAD 00000041757HL6 435586PROT 00000057200HL8 435658RAD 00000088306HL6 505983ORTHPROT 00000020347HL1 508698NEPATS 00000049345HL2 573882NSCRAD1 00000064320HL5 601788RAD1 00000048917HL9 601968MAERM1 00000016587HL8 602285PROT2 00000106226HL4 608366PRO 00000047063HL3 616752NWPROTEUS 00000033643HL8 623327XR3 00000059646HL0 630312PROT1 00000082840HL0 630856SCPRO 00000057436HL8 702396XR1 00000102867HL9 703771PROT 00000049772HL7 703784RAD1 00000067466HL3 706641CTC 00000024904HL5 708226PROT 00000041647HL9 708226RM2 00000062869HL3 757606PRO1 00000063690HL2 770252GBJ3 00000049128HL2 801IMCXR 00000036909HL0 804594RM4 00000112434HL6 805681RAD4 00000107242HL0 805681RAD5 00000027096HL7 814833PROT 00000046048HL5 818409RAD3 00000081590HL2 870245PROT 00000041480HL5 904264PRO 00000050595HL8 904381RAD 00000068296HL3 912279CCGA 00000062303HL3 912748PROT 00000035901HL8 918352DRAD1 00000061157HL4 MCCPROT1 00000061158HL2 MCCPROT2 103733HL2 918494XRTRAUMA2 00000020349HL7 210297NCRAD 00000044647HL6 252466CPRAD1 00000060369HL6 303269RM2 00000089696HL9 402294EBPROT 00000038564HL1 520202PRO1 00000038565HL8 520202PRO2 00000073629HL8 609878PRO1 00000075649HL4 609878PRO2 00000045941HL2 816282LSPRO1 00000078007HL2 817250RAD 00000061302HL6 856341PROT 00000059336HL8 203932PROT2 00000106552HL3 412232PROT1 00000019948HL9 812256RT1 00000045545HL1 662434RM2 00000046670HL6 808KWAJPROT 00000084213HL8 412315PROT1 00000050315HL1 318368PRO 00000111660HL7 276694PRO 00000068951HL3 256486XR1 00000058725HL3…
FDA’s list runs to 80,192 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.
USA: All states in continental US including, Guam, DC. OUS; ARAB EMIRATES, AUSTRIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KUWAIT, LATVIA, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PHILIPPINES, POLAND, POLYNESIA, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM.
The states and territories these words name
- District of Columbia
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.
The words say it went outside the United States too.
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 Dec 8, 2014.
- FDA classified it on Jan 12, 2015.
- FDA’s Enforcement Report published it on Jan 21, 2015.
- FDA terminated it on Feb 3, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, 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 80,192 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.