Reported Aug 22, 2018 · Terminated
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage:…
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. angiography system. Model 108482801084828110848282108482831084835310848354 & 10848355
- Product UsageArtis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis
- Lot codes and dates
- Model 10848280 - Serial Numbers
103221103061103232103217103030103218103220103013103053103039103050103008103207103222103035103230103258103001103239103263103048103028103241103212103254103255103257103245103040103253
- Model 10848281 - Serial Numbers
209 of 209 codes
109033109135109141109502109123109400109344109210109080109074109417109352109388109479109418109190109191109197109198109305109405109437109119109346109419109421109016109118109493109166109496109460109137109155109379109300109187109228109327109412109066109067109068109084109133109134109365109217109366109203109011109367109169109096109159109358109202109130109490109378
- Model 10848282 - Serial Numbers
177 of 177 codes
121185121430121406121061121195121336121089121094121169121006121013121040121368121208121445121446121062121448121082121011121039121371121134121374121053121054121422121014121112121209121325121357121051121402121004121167121378121369121133121200121163121364121314121396121018121154121351121354121418121442121151121036121205121340121365121137121324121012121049121078
- Model 10848283 - Serial Numbers
117012117136117324117108117001117023117330117329117315117021117316117125117029117006117312117129117112117034117020117018117124117030117026117123117100117134117307117117117111117304117024117127117325117303117310117314117309117113117322117014117040117041117114117009
- Model 10848353 - Serial Numbers
105033105032105007105105105028105110105120105018105119105114105115105025105016105026105027105017105100105112105029105030105031
- Model 10848354 - Serial Numbers
111005111122111124111125111002111113111103111109111121111003111110111101111011111017111010111115111116111117111118111119111120111000111104111112111012111107111106111123
- Model 10848355 - Serial Numbers
123225123026123043123031123236123053123202123050123008123035123211123003123011123032123208123209123231123013123014123206123207123219123213123025123036123220123221123222123022123229123205123201123023123024123235123224123232123233123234123027123049123230123055123056123037123216123010123046123052123200123015123016123212
- Model 10848280 - Serial Numbers
- Amount recalled
- 605 units in total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Potential hardware issue which may cause thermal effects and possible damage to system parts.
This product could cause temporary or reversible health problems — stop using it.
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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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