Reported Mar 1, 2023 · Ongoing

Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number:…

Siemens Medical Solutions USA, Inc.

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: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418

Is this the product you have?

  • Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies
  • Model Number10502200
Lot codes and dates
  • UDIN/A
  • S/N60040 60018 60223 60015
  • Expanded Recall 2/24/23S/N:

    93 of 93 codes

    • 60011
    • 60037
    • 60041
    • 60043
    • 60051
    • 60055
    • 60056
    • 60062
    • 60067
    • 60071
    • 60072
    • 60075
    • 60076
    • 60081
    • 60087
    • 60089
    • 60092
    • 60093
    • 60095
    • 60103
    • 60111
    • 60114
    • 60118
    • 60133
    • 60138
    • 60140
    • 60141
    • 60143
    • 60146
    • 60155
    • 60162
    • 60171
    • 60172
    • 60173
    • 60178
    • 60183
    • 60184
    • 60186
    • 60187
    • 60188
    • 60192
    • 60194
    • 60196
    • 60204
    • 60208
    • 60214
    • 60219
    • 60220
    • 60221
    • 60225
    • 60227
    • 60228
    • 60230
    • 60231
    • 60234
    • 60238
    • 60239
    • 60255
    • 60259
    • 60262
Amount recalled
4 units. Expanded Recall: 93 units

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was recalled

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:40 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.