CLASS II ONGOING Device recall · Reported 27 Apr 2022 · FDA Enforcement Report

Artis zeego recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Artis zeego, distributed nationwide in the US. The recall was initiated on 23 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 4056869010083; Serial Numbers: 160851 160879 161046 160395 160484 161041 160351 161218 160999 161032 161204 161226 160838 160449 160852 160463 160411 160106 160134 160136 160953 160347 160913 161206 160961 160312 160877 161008 160488 160997 160864 160448 160937 160965 160427 160455 160884 160486 161236 160435 160451 160823 160951 160384 160431 160100 160916 160814 160872 160391 160470 160321 160376 160915 160447 161021 160481 160401 160119 160403 160404 160871 160989 161051 160874 161223 161007 160862 160438 160860 160378 160419 160889 160450 160854 160429 160149 160878 160137 160152 160153 160154 160138 160446 160368 160957 160992 160394 160856 160432 160147 160433 160483 160402 161005 161209 160813 160998 160356 160425 160148 160337 160460 160485 160443 160370 160912 160381 160412 161215 160919 161217 160407 160876 160861 160325 160885 160910 161000 160494 160390 161050 160507 160144 160833 160001 160363 160825 160341 160139 160942 160816 160430 160873 161233 161234 160840 160006 160462 160505 160956 160445 160322 160323 160382 160421 160474 160428 160116 161016 161017 160131 160318 160369 160498 160413 160414 160128 160373 161004 160978 160551 160327 160865 160830 161224 161235 160338 160141 Additional Serial Numbers as of 10/4/23: 160501 160519 160406 160900 160850 160959 160461 160903 126206 160905 160930 160967 160925 160469

Quantity recalled183 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0973-2022
FDA event ID: 89860
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 23 Feb 2022
FDA classified: 21 Apr 2022
Reported: 27 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

23 Feb 2022	Recall initiated by company
21 Apr 2022	Classified by FDA	+57 days
27 Apr 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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".

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Artis zeego, Model Number 10280959

Where it was distributed

US Nationwide.

Nationwide

Questions about this recall

Is Artis zeego recalled?

Yes. Siemens Medical Solutions USA recalled Artis zeego on 23 Feb 2022. The recall is Class II and its status is Ongoing. Recall number Z-0973-2022.

Why was it recalled?

Which lots are affected?

UDI: 4056869010083; Serial Numbers: 160851 160879 161046 160395 160484 161041 160351 161218 160999 161032 161204 161226 160838 160449 160852 160463 160411 160106 160134 160136 160953 160347 160913 161206 160961 160312 160877 161008 160488 160997 160864 160448 160937 160965 160427 160455 160884 160486 161236 160435 160451 160823 160951 160384 160431 160100 160916 160814 160872 160391 160470 160321 160376 160915 160447 161021 160481 160401 160119 160403 160404 160871 160989 161051 160874 161223 161007 160862 160438 160860 160378 160419 160889 160450 160854 160429 160149 160878 160137 160152 160153 160154 160138 160446 160368 160957 160992 160394 160856 160432 160147 160433 160483 160402 161005 161209 160813 160998 160356 160425 160148 160337 160460 160485 160443 160370 160912 160381 160412 161215 160919 161217 160407 160876 160861 160325 160885 160910 161000 160494 160390 161050 160507 160144 160833 160001 160363 160825 160341 160139 160942 160816 160430 160873 161233 161234 160840 160006 160462 160505 160956 160445 160322 160323 160382 160421 160474 160428 160116 161016 161017 160131 160318 160369 160498 160413 160414 160128 160373 161004 160978 160551 160327 160865 160830 161224 161235 160338 160141 Additional Serial Numbers as of 10/4/23: 160501 160519 160406 160900 160850 160959 160461 160903 126206 160905 160930 160967 160925 160469

Where was it sold?

US Nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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