Reported Oct 8, 2014 · Terminated

GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended…

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?

  • GE Healthcare Precision 500D, Classical R&F System
  • Product UsageThe Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations
Lot codes and dates
  • Mfg Lot or Serial # System ID

    408 of 408 codes

    • 00000015997MO7
    • 260347RF
    • 00000149474MO9
    • 423778ENRF1
    • 00000149476MO4
    • 216343R1
    • 00000149477MO2
    • 423778ERF1
    • 00000149478MO0
    • 407296PRE
    • 00000149479MO8
    • 765482WR2
    • 00000149480MO6
    • 478633PDI3
    • 00000149481MO4
    • 404321P500D
    • 00000149482MO2
    • 435865500D
    • 00000149483MO0
    • 210297NCRF1
    • 00000149484MO8
    • 334705EA3
    • 00000149485MO5
    • 314577GC64
    • 00000149486MO3
    • 423224RF1
    • 00000149487MO1
    • 847432HP8
    • 00000149488MO9
    • 423778ERF2
    • 00000149489MO7
    • 210616MCTRF
    • 00000149490MO5
    • 773633EP500
    • 00000149491MO3
    • 763520N8
    • 00000149492MO1
    • 773CMHCSRF
    • 00000149493MO9
    • 904202RF
    • 00000149495MO4
    • 208557RM1
    • 00000149496MO2
    • 515226RF
    • 00000149498MO8
    • 847535RF1
    • 00000149499MO6
    • 704210RX5
    • 00000149500MO1
    • 515226RF2
    • 00000149501MO9
    • 970244AMPRF2
    • 00000149502MO7
    • 215750PRECIS1
    • 00000149503MO5
    • 504447P500
    • 00000149505MO0
    • 602344RM7
    • 00000149506MO8
    • 609584RM1
Amount recalled
204 (199 US, 5 OUS).

Where it was sold

Why it was recalled

GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging 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 Feb 20, 2015 · Data as of Sep 19, 5:59 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.