Reported Feb 17, 2016 · Terminated

GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic…

GE Medical Systems, 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 Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

  • GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Lot codes and dates
  • Lot or serial
  • numbers include but not limited to

    116 of 116 codes

    • 00000086177HL3
    • 00001028564WK1
    • 115226HL3
    • 00000083538HL9
    • 00000092940HL6
    • 00000084909HL1
    • 00000081798HL1
    • 120634HL1
    • 00000084729HL3
    • 00000084161HL9
    • 00000082463HL1
    • 00000080868HL3
    • 120832HL1
    • 00000089868HL4
    • 00000082736HL0
    • 00000093379HL6
    • 00000092616HL2
    • 00000092633HL7
    • 00000081160HL4
    • 00000077253HL3
    • 00000076913HL3
    • 00000078498HL3
    • 00000084160HL1
    • 00000078315HL9
    • 00000082726HL1
    • 00000085039HL6
    • 00000080635HL6
    • 00000091403HL6
    • 00000085598HL1
    • 00000085661HL7
    • 00000077923HL1
    • 00000081481HL4
    • 00001027046WK0
    • 00000081152HL1
    • 00000086364HL7
    • 00000092622HL0
    • 00000085000HL8
    • 00000084999HL2
    • 00000084725HL1
    • 00000083029HL9
    • 00000078313HL4
    • 00000084162HL7
    • 00000083020HL8
    • 00000077471HL1
    • 00000083019HL0
    • 00000082738HL6
    • 00000083598HL3
    • 00000092618HL8
    • 00000084180HL9
    • 00000085594HL0
    • 00000084917HL4
    • 00000076790HL5
    • 00000091413HL5
    • 00001028931WK2
    • 00000102856WK4
    • 00001028927WK0
    • 00001028924WK7
    • 00000084159HL3
    • 00000084422HL5
    • 00001029525WK1
Amount recalled
126

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.

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 7, 2016 · Data as of Sep 19, 6:00 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.