Legacy
Medical device recall Z-0909-2017. Published in FDA’s Enforcement Report on Jan 4, 2017.
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 4, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 41 states named in where it went
- Total for all products 1,598 (USA 824, OUS 774) 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 is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Legacy
Total for all products 1,598 (USA 824, OUS 774), 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 00000118203MO9 256235ORF1 00000118220MO3 256235ORF2 00000100096MO7 205655LRF 00000080072YY2 205783LRF2 00000119875MO3 205930LRF Not Available 205801KRF4 00000026146YY1 205793FLEG 00000047927YY9 205793FR1…
Every code shown here, 1,998 characters
Mfg. Lot or Serial # System ID 00000118203MO9 256235ORF1 00000118220MO3 256235ORF2 00000100096MO7 205655LRF 00000080072YY2 205783LRF2 00000119875MO3 205930LRF Not Available 205801KRF4 00000026146YY1 205793FLEG 00000047927YY9 205793FR1 00000089624MO1 205877LRF2 00000047907YY1 205534RM2 00000094699MO6 256517EF2 00000089628MO2 256534RM1 00000113953MO4 205387LRF 00000034291YY5 334293JLD3 00000063480YY8 256386LD1 00000063481YY6 256386LD2 00000119881MO1 205345RF3 00000119916MO5 205554VAL 00000128623MO6 479553RF2 00000118229MO4 501520RF1 00000100110MO6 501622SJR4 00000071209YY1 501751NWX2 00000146291MO0 520432RM1 00000063528YY4 480264RF1 00000119856MO3 480821RM2 00000119873MO8 480821RM2 00000128466MO0 928729RM4 00000128464MO5 928729RM5 00000071297YY6 602588LEGACY 00000128589MO9 602588ROOM5 00000063529YY2 602856LEG 00000063617YY5 602835RM2 00000118196MO5 602835RM3 00000118194MO0 602239RMF 00000063638YY1 602879RM1 00000128507MO1 623445LEG 00000119871MO2 623879RM3 00000071252YY1 602994DRS 00000094664MO0 520742LEGACY 00000071291YY9 520742RM1 00000119898MO5 520872RM3 00000023695YY0 619242RF3 00000100087MO6 209386ATWRF 00000063549YY0 661282XR 00000063581YY3 650696M6 00000071217YY4 619725RM4 00000146295MO1 818884LRF1 00000063461YY8 916537MXF Not Available 209992CP1 00000026093YY5 818331SFX 00000023850YY1 707443JR5 00000022135YY8 209221TCX 00000100070MO2 831395RF2 00000153568M01 858626RF6 00000153565M07 858626RF7 00000128636MO8 925734RF1 00000113872MO6 RADNETRF130 00000063584YY7 323669ADV 00000047971YY7 209225LEG3 00000052191YY4 336835HCR1 00000031396YY5 510370RFDG2 00000047998YY0 510372RF2 00000052100YY5 510372RF2 00000080068YY0 209577LEG 00000119878MO7 RADNETRF138 00000052169YY0 RADNETRF174 00000026132YY1 619485RM3 00000119892MO8 909788LF3 00000118227MO8 909788LF4 00000026094YY3 916423AVTX2 00000071284YY4 480860RM10 00000022205YY9 1443 00000094667MO3 619487RF1 00000146280MO3 619543RF4 00000063775YY1 415923LEGACYGI 00000071207YY5 415387C1 00000063587YY0 415387C2 00000047912YY1…
FDA’s list runs to 16,674 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.
US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. OUS: Algeria Armenia Australia Austria Brazil Canada Chile China Denmark Egypt France Germany Guatemala Honduras Hong Kong Hungary Iceland India Ireland Italy Japan Korea Libya Mexico Netherlands Netherlands Peru Poland Portugal Russia Saudi Arabia Serbia Sierra Leone Slovakia Spain Taiwan Thailand Turkey United Arab Emirates United Kingdom Venezuela Vietnam
The states and territories these words name
41 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Virginia
- Washington
- West Virginia
- Wyoming
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 Nov 21, 2016.
- FDA classified it on Dec 23, 2016.
- FDA’s Enforcement Report published it on Jan 4, 2017.
- FDA terminated it on Sep 26, 2017.
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 16,674 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.