Reported Feb 17, 2016 · Terminated

GE Healthcare, Optima XR200amx, 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, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Lot codes and dates
  • Lot or serial numbers include
  • but not limited to

    693 of 693 codes

    • 00001031869WK9
    • 00001031925WK9
    • 00000081156HL2
    • GEGR2170
    • 00001033726WK9
    • 00000119120HL4
    • 00000084104HL9
    • 00001033405WK0
    • 00000085648HL4
    • 00001033548WK7
    • 1035415WK7
    • 124175HL1
    • 122205HL8
    • 1036207WK7
    • 00000086387HL8
    • 00000104902HL2
    • 00000087904HL9
    • 00000087902HL3
    • 00000106045HL8
    • 00000105791HL8
    • 00000083607HL2
    • 00000090594HL3
    • 00000090597HL6
    • 00001030061WK4
    • 00001030140WK6
    • 00001030142WK2
    • 114185HL2
    • 00001031534WK9
    • 00001031533WK1
    • 00001031696WK6
    • 00000092062HL9
    • 00001028273WK9
    • 00000106054HL0
    • 00000106067HL2
    • 00000105797HL5
    • 00000106074HL8
    • 00000105801HL5
    • 00000104928HL7
    • 00000093370HL5
    • 00000089482HL4
    • 00000085430HL7
    • 00000091765HL8
    • 120821HL4
    • 00000086171HL6
    • 00000089492HL3
    • 00000089863HL5
    • 00000104898HL2
    • 00000108421HL9
    • 00000092383HL9
    • 00000093388HL7
    • 00001032768WK2
    • 00000104929HL5
    • 00000104507HL9
    • 00000105458HL4
    • 00000090610HL7
    • 00000086388HL6
    • 00000083023HL2
    • 00000085899HL3
    • 00000080694HL3
    • 00000102536HLO
Amount recalled
895

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, 6:01 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.