Reported Sep 7, 2022 · Ongoing
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q…
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?
7 of 7 products
| Model / number | Product as published |
|---|---|
10848280 | Artis Q ceiling |
10848281 | Artis Q biplane |
10848282 | Artis Q zeego |
10848283 | Artis Q.zen floor |
10848353 | Artis Q.zen ceiling |
10848354 | Artis Q.zen biplane |
10848355 | — |
- Lot codes and dates
- Artis Q floor- Model No. 10848280
- UDI-DI4056869009971 Serial Numbers***Updated 9/23/22*** 103035 ***Updated 1/9/23*** 103444 103050 Artis Q ceiling- Model No. 10848281
103221103217104049103409103232104005104027132508132510103359104051103220104029103365104025103286103222132507104047132502132509132500103241103212103254103255
- UDI-DI4056869009988 Serial Numbers***Updated 9/23/22***
176 of 176 codes
109552110088110199110059110103133503110166109123110005109344109628110058110156110176110180110147110181110056110158109074109479109197109421109792109738109405110195109437109645109166110067110161110184110169110119109747110144109760110095110167110192110131109169110093109769133202109202110109110128109378109384110096109621133504110198109015110069110106110139109211
***Updated 1/9/23*** 109417 109066 110048 110014 110233 Artis Q biplane- Model No. 10848282110223110227110224110228109225109358133508133509
- UDI-DI4056869009995 Serial Numbers***Updated 1/9/23*** 121015 121309 121633 122032 121653 121393 134506 Artis Q zeego- Model No. 10848283
141 of 141 codes
122049121665121564122025121627121185121336122012121471121467121612122022121094122040121006122021122028121013121501121208121459121011122037121054121422121209121325121357121369121133121200121163121364122039121154121418121442122046121205122034121137121012121049122042121332121183121455121019121381121352122050121434121165121625121415121355121010121210121573121215
- UDI-DI4056869010007 Serial Numbers***Updated 9/23/22*** 117136 Artis Q.zen floor- Model No. 10848353
117316117330117006117034117026117123117111117024117309117113117322117040117041
- UDI-DI4056869010014 Serial Numbers 105007 105503 105018 105119 105125 Artis Q.zen ceiling- Model No. 10848354
- UDI-DI4056869010021 Serial Numbers***Updated 1/9/23*** 111529 111530 111528 ***Updated 1/13/23*** 111535 Artis Q.zen biplane- Model No. 10848355
111162111163111137111502111523111174111510111527111155111140111507111124111512111521111133111110111101111524111526111149111109111151111130111517111513111017111120111127111157111142111525111107111514111128
- UDI-DI4056869010038 Serial Numbers***Updated 1/9/23*** 123225 123513
123245123026123031123050123008123255123247123254123221123508123505123510123205123509123230123239123010
- Amount recalled
- 1,389 (590 US; 799 OUS) (Total)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
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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