Reported Apr 27, 2022 · Ongoing

Artis Q.zen ceiling, Model Number 10848354

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 Q.zen ceiling, Model Number 10848354
Lot codes and dates
  • UDI4056869010021
  • Serial Numbers

    80 of 80 codes

    • 111160
    • 111162
    • 111163
    • 111137
    • 111502
    • 111139
    • 111174
    • 111185
    • 111503
    • 111005
    • 111002
    • 111145
    • 111176
    • 111510
    • 111155
    • 111179
    • 111140
    • 111507
    • 111122
    • 111168
    • 111170
    • 111173
    • 111512
    • 111141
    • 111508
    • 111521
    • 111133
    • 111003
    • 111111
    • 111103
    • 111101
    • 111011
    • 111182
    • 111184
    • 111143
    • 111150
    • 111164
    • 111183
    • 111504
    • 111149
    • 111109
    • 111151
    • 111129
    • 111121
    • 111130
    • 111517
    • 111513
    • 111017
    • 111010
    • 111115
    • 111116
    • 111117
    • 111119
    • 111104
    • 111148
    • 111127
    • 111175
    • 111506
    • 111112
    • 111131
  • Additional Serial Numbers as of 10/4/23111125
Amount recalled
81 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, 5:39 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.