GE Healthcare Proteus XR/a with wall stand
Medical device recall Z-1248-2015. Published in FDA’s Enforcement Report on Mar 18, 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 Mar 18, 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 34 states named
- 192 (131 US, 61 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?
Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator.
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 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
192 (131 US, 61 OUS)., 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 00000014277HL8 503246PRO 00000014127HL5 202715PRO 00000013133HL4 206215RM1 00000013085HL6 206543HECED 00000014123HL4 208785RAD 00000014689HL4 208882GX1A 00000010591HL6 208893RAD2 00000014556HL5 209943SJRM2…
Every code shown here, 1,986 characters
Mfg Lot or Serial # System ID 00000014277HL8 503246PRO 00000014127HL5 202715PRO 00000013133HL4 206215RM1 00000013085HL6 206543HECED 00000014123HL4 208785RAD 00000014689HL4 208882GX1A 00000010591HL6 208893RAD2 00000014556HL5 209943SJRM2 00000013410HL6 214320RAD1 00000014413HL9 215918RAD1 00000014555HL7 215918RAD1 00000014684HL5 215918RAD2 00000014116HL8 216343R3 00000014276HL0 216343R4 00000013780HL2 217258SR3 00000024745HL2 217333LXR2 00000014020HL2 219284PRO1 00000014687HL8 225638R1 00000014119HL2 248652PROT3 00000014679HL5 262321RAD1 00000015410HL4 281392PRO 00000014424HL6 304257PROT 00000011358HL9 304354PROD 00000015166HL2 309655FNCR1 00000015168HL8 309655FNCR2 00000012515HL3 313369PROT 00000013910HL5 314768MRM8 00000014562HL3 314966JRM2A 00000011363HL9 318425LR1 00000013785HL1 319382PROTXR 00000014412HL1 330270PX 00000015409HL6 330438R3 00000014282HL8 330489XR3 00000014423HL8 330675PX 00000011060HL1 336768OSAB 00000010841HL5 336768OSCD 00000011055HL1 336768OSEF 00000010842HL3 336768OSGH 00000014686HI0 352401RAD3 00000011577HL4 360414SJRM4 00000015171HL2 360425LRP 00000013908HL9 402481PLRAD 00000015055HL7 404624METRO1 00000011195HL5 405447ORT 00000014283HL6 405744OSU 00000015047HL4 405949BCH 00000011580HL8 408636PROTEUS 00000015420HL3 414266RM8 00000013094HL8 419228LMP 00000014122HL6 419251RAD1 00000011198HL9 419946PRO2 00000013393HL4 425883ER 00000014128HL3 440835RAD1 00000014682HL9 440988RAD 00000015062HL3 502587JHC 00000012526HL0 502868RAD2 00000013390HL0 505272RM1 00000013610HL1 505835RM1 00000012524HL5 509684MC2 00000011359HL7 509684MCC1 00000014022HL8 517463RM3 00000013611HL9 517545RMONE 00000011199HL7 517684RM1 00000012510HL4 518292RAD2 00000012513HL8 518292RAD4 00000014683HL7 518483RAD 00000015050HL8 518583RAD7 00000012511HL2 518608RAD1 00000011177HL3 520742PROTEUS 00000014415HL4 520886PRO 00000013909HL7 570321TOMO 00000013600HL2 603352KC02 00000012509HL6 606474BFM 00000014021HL0 608647RAD 00000014115HL0 610280PROT1 00000013783HL6 610377PRO…
FDA’s list runs to 4,946 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-US (nationwide) including the states of AK, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI,and WV, and the countries of ARGENTINA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, IRELAND, ITALY, JAPAN, NEW ZEALAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SLOVAKIA, SPAIN, and UNITED KINGDOM.
The states and territories these words name
34 states and territories.
Every one of them
- Alaska
- Arizona
- California
- Colorado
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Maryland
- Michigan
- Missouri
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West 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.
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 Jan 30, 2015.
- FDA classified it on Mar 6, 2015.
- FDA’s Enforcement Report published it on Mar 18, 2015.
- FDA terminated it on Sep 15, 2015.
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 4,946 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.