Reported Aug 28, 2013 · Terminated

GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic…

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 Product UsageThe Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations
Lot codes and dates
  • FMI# 10879: CRT Monitor Suspension Supporting Hardware Serial #

    445 of 445 codes

    • 00000002608GQ8
    • 00000002734GQ2
    • 00000002735GQ9
    • 00000002736GQ7
    • 00000002838GQ1
    • 00000003208GQ6
    • 00000003209GQ4
    • 00000004078GQ2
    • 00000004079GQ0
    • 00000004083GQ2
    • 00000004084GQ0
    • 00000004086GQ5
    • 00000004087GQ3
    • 00000004102GQ0
    • 00000004103GQ8
    • 00000004104GQ6
    • 00000004105GQ3
    • 00000004106GQ1
    • 00000004107GQ9
    • 00000004109GQ5
    • 00000004873GQ6
    • 00000004874GQ4
    • 00000004875GQ1
    • 00000004876GQ9
    • 00000004878GQ5
    • 00000004881GQ9
    • 00000004882GQ7
    • 00000005522GQ8
    • 00000005523GQ6
    • 00000005524GQ4
    • 00000005525GQ1
    • 00000005527GQ7
    • 00000005528GQ5
    • 00000005529GQ3
    • 00000005530GQ1
    • 00000005885GQ9
    • 00000005886GQ7
    • 00000005887GQ5
    • 00000006565GQ6
    • 00000006566GQ4
    • 00000006742GQ1
    • 00000006743GQ9
    • 00000006744GQ7
    • 00000006745GQ4
    • 00000006746GQ2
    • 00000006747GQ0
    • 00000006748GQ8
    • 00000006752GQ0
    • 00000006753GQ8
    • 00000006755GQ3
    • 00000006756GQ1
    • 00000006757GQ9
    • 00000006758GQ7
    • 00000007111GQ8
    • 00000007112GQ6
    • 00000007113GQ4
    • 00000007114GQ2
    • 00000007115GQ9
    • 00000007116GQ7
    • 00000007117GQ5
Amount recalled
445 (421 US, 24 OUS)

This recall covers 2 products

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

Where it was sold

Why it was recalled

GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and

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 Nov 26, 2013 · Data as of Sep 19, 4:53 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.