Prestige VH
Medical device recall Z-0913-2017. 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?
Prestige VH
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 Not Available 708425PREST 00000063646YY4 314525APR 00000034238YY6 910249LRF3 00000023833YY7 919472CGRFA 00000063653YY0 724284R4 00000052120YY3 713442KPDRS 00000063577YY1 509458DR10 00000048069YY9 AH4317XR04…
Every code shown here, 1,258 characters
Mfg. Lot or Serial # System ID Not Available 708425PREST 00000063646YY4 314525APR 00000034238YY6 910249LRF3 00000023833YY7 919472CGRFA 00000063653YY0 724284R4 00000052120YY3 713442KPDRS 00000063577YY1 509458DR10 00000048069YY9 AH4317XR04 00000052117YY9 AH3221XR06 00000026253YY5 AH5681XR02 Not Available CS1029RX01 00000113920MO3 EG1112RX05 00000023862YY6 M4159446 00000034208YY9 M4160037 Not Available M1875113 00000039660YY6 M4500608 00000048049YY1 M2880713 00000026209YY7 M4046528 Not Available M2838405 Not Available M2663805 00000089618MO3 M4202921 00000031488YY0 M9624214 00000023814YY7 M4496929 00000023829YY5 M4496929 Not Available B4192927 00000034269YY1 HC2834XR11 00000063668YY8 HC1627XR14 00000026202YY2 HC0393XR02 00000023796YY6 HC0760XR01 00000026216YY2 PC0545XR04 Not Available 490314XR02 Not Available MC5880XR03 Not Available CC2149XR02 Not Available IS1002RX01 00000063686YY0 IE1012RX03 00000063667YY0 IE1025RX02 Not Available IE1006RX07 00000063609YY2 A5250603 Not Available A5127805 00000034283YY2 NO1004RX01 00000026203YY0 NO1041RX01 Not Available NO1104RX01 00000048004YY6 NO1016RX02 00000080076YY3 PPR00132 00000063713YY2 PPR59013 00000026248YY5 RU1306RX01 00000063560YY7 CE165306 00000063616YY7 05074FLU02 00000063755YY3 38853103XRMET
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.”
- 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.