Reported Apr 27, 2022 · Ongoing

Artis zee floor, Model Number 10094135

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?

  • Artis zee floor, Model Number 10094135
Lot codes and dates
  • UDI4056869010045
  • Serial Numbers

    295 of 295 codes

    • 138481
    • 137729
    • 124071
    • 138390
    • 135944
    • 137623
    • 135111
    • 135112
    • 124267
    • 124253
    • 137165
    • 124335
    • 124338
    • 124400
    • 137391
    • 137714
    • 124081
    • 135120
    • 137282
    • 135358
    • 137618
    • 137226
    • 135757
    • 136513
    • 137103
    • 137118
    • 137461
    • 135102
    • 136042
    • 138124
    • 138132
    • 135927
    • 137510
    • 138260
    • 138012
    • 138058
    • 137193
    • 135986
    • 135935
    • 135953
    • 138055
    • 124303
    • 135841
    • 138497
    • 135200
    • 135201
    • 135279
    • 124061
    • 135879
    • 135229
    • 136113
    • 135990
    • 138035
    • 138214
    • 137479
    • 138156
    • 124083
    • 137532
    • 137540
    • 136077
  • Additional Serial Numbers as of 10/4/23
    • 136450
    • 135352
    • 124201
    • 124089
    • 136548
    • 136568
    • 124015
    • 136607
    • 136586
    • 136555
Amount recalled
305 systems

This recall covers 18 products

The agency filed one notice per product. You are reading one of them; the other 17 are below.

5 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

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, 6:57 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.