Reported Feb 17, 2016 · Terminated

GE Healthcare, Optima XR220amx, 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 XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Lot codes and dates
  • Lot or Serial
  • numbers including but not limited to

    1,966 of 1,966 codes

    • 00001033715WK2
    • 12535HL3
    • 00000078321HL7
    • 00000096815HL6
    • 00000081147HL1
    • 00001032621WK3
    • 00000092076HL9
    • 00000092382HL1
    • 00000460115GE9
    • 00000079932HL0
    • D3s14793
    • 00000088642HL4
    • 116635HL4
    • 120632HL5
    • GEGR2411
    • GEGR5073
    • 00001027151WK8
    • 00000129105HL3
    • 261417HP0
    • 261416HP2
    • 1035189WK8
    • 00000084720HL2
    • 00000087109HL5
    • 00000100735HL0
    • 121206HL7
    • 125007HL5
    • 125019HL0
    • 1028231WK7
    • 00000126237HL7
    • 00000102072HL6
    • 00000092394HL6
    • 00000115802HL1
    • 124167HL8
    • 00001033721WK0
    • 00000108520HL8
    • 00000087928HL8
    • 00000111794HL4
    • 00000110657HL4
    • 00000092629HL5
    • 119090HL9
    • 00000442129GE3
    • 00000128179HL9
    • 00000110710HL1
    • 83621HL3
    • 00000082207HL2
    • 1034762WK3
    • 00000081499HL6
    • 00000088705HL9
    • 00000085601HL3
    • 00001031247WK8
    • 00000084721HL0
    • 00000084410HL0
    • 00000086179HL9
    • 1033866WK3
    • 00000084286HL4
    • 00000096817HL2
    • 00000092948HL9
    • 00000106841HL0
    • 00000105475HL8
    • 00001033220WK3
Amount recalled
2389

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.