Reported Jan 4, 2017 · Terminated

Prestige II

GE Healthcare, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

  • Prestige II
Lot codes and dates
  • Mfg. Lot or Serial # System ID
    • 00000128555MO0
    • 850526JR3
    • 00000089643MO1
    • 305227PRESTIGE1
    • 00000094666MO5
    • 305227PRESTIGE2
    • 00000063792YY6
    • 708216REM1
    • 00000100104MO9
    • 219416PRE
    • 00000118238MO5
    • 317338SVP
    • 00000119906MO6
    • 228314RF
    • 00000113951MO8
    • 662513RF2
    Not Available
    • 662513RF1
    • 00000063697YY7
    • 919472CGRFB
    • 00000113961MO7
    • 718262REM1
    • 00000052137YY7
    • 843692PRES
    • 00000010115MO5
    • 803778RF1
    • 00000128514MO7
    • 423493PRF4
    Not Available 901226R9 Not Available
    • 204623RF1
    • 00000128614MO5
    • 519685REM
    • 00000063717YY3
    • 905895RM3
    • 00000113955MO9
    • 905358REM
    • 00000128544MO4
    • 519631REM
    • 00000128595MO6
    • 326582XF1
    • 00000063685YY2
    • 082408040013
    • 00000063685YY2
    • 082408040013
    • 00000063761YY1
    • 082408100085
    • 00000063716YY5
    • EG1024RX01
    Not Available HDAR01XR02 00000128613MO7 IS1001RF01 00000063688YY6 A5181620 Not Available A5487204 00000063749YY6 B5130612 Not Available 0850080467 Not Available
    • LY1006XR03
    • 00000119921MO5
    • 0853080154
    • 00000063700YY9
    • 0853080151
    • 00000063700YY9
    • 0853080151
    • 00000119921MO5
    • 0853080154
    Not Available 38828380XRNOR 00000063753YY8 38811857XRAND 00000063767YY8 0859080008
Amount recalled
Total for all products 1,598 (USA 824, OUS 774)

This recall covers 13 products

The agency filed one notice per product. You are reading one of them; the other 12 are below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 26, 2017 · Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.