Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions has recalled certain Artis Q, Artis Q.zen, Artis pheno, and Artis icono X-ray imaging systems due to a potential hardware issue involving a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, the system will be unable to release X-rays until the system is shut down and restarted. Approximately 1,389 affected systems have been distributed worldwide, including 590 units in the United States and 799 units internationally across multiple countries.
The recall affects specific serial numbers of floor, ceiling, biplane, and zeego models of these systems. Consumers who own or operate an affected system should check whether their equipment's serial number matches those listed in the recall notice to determine if their device is involved. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution: US (nationwide) and OUS (Foreign) to countries of: United Arab Emirates; Armenia; Angola; Argentina; Austria; Australia; Bangladesh; Belgium; Bulgaria; Bahrain; Brazil; Canada; Switzerland; China; Colombia; Costa Rica; Czech Republic; Germany; Denmark; Dominican Republic; Algeria; Estonia; Egypt; Spain; Finland; France; United Kingdom; Greece; Guatemala; Hong Kong; Croatia; Quantity: 1,389 (590 US; 799 OUS) (Total) Lot/code info: Artis Q floor- Model No. 10848280 UDI-DI: 4056869009971 Serial Numbers 103221 103217 104049 103409 103232 104005 104027 132508 132510 103359 104051 103220 104029 103365 104025 103286 103222 132507 104047 132502 132509 132500 103241 103212 103254 103255 ***Updated 9/23/22*** 103035 ***Updated 1/9/23*** 103444 103050 Artis Q ceiling- Model No. 10848281 UDI-DI: 4056869009988 Serial Numbers 109552 110088 110199 110059 110103 133503 110166 109123 110005 109344 109628 110058 110156 110176 110180 110147 110181 110056 110158 109074 109479 109197 109421 109792 109738 109405 110195 109437 109645 109166 110067 110161 110184 110169 110119 109747 110144 109760 110095 110167 110192 110131 109169 110093 109769 133202 109202 110109 110128 109378 109384 110096 109621 133504 110198 109015 110069 110106 110139 109211 109726 110185 110075 109674 109627 109780 110179 110063 110047 110102 109656 109309 110023 110110 110159 110065 110052 109057 109915 110191 109604 110136 110201 109457 110072 109034 109129 110145 109181 109884 109643 109678 110081 109330 109058 110182 109380 109222 109435 110054 109188 109518 109458 109155 109379 109538 109752 109659 110053 110107 109591 109630 109393 110196 110175 109920 110193 110187 110077 109164 110079 109362 109762 110099 110113 109717 110134 109564 109813 110049 110117 110066 109088 110186 109397 109685 109096 109159 110154 110183 109715 109364 110100 110129 110188 110190 109463 110083 110091 109048 109742 109301 109020 109036 109818 110115 109664 109163 1091
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.