FDA Device recall Z-2747-2018
Artis Q. angiography system
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of Artis Q. angiography system by Siemens Medical Solutions Usa, citing potential hardware issue which may cause thermal effects and possible damage to system parts.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2747-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-22 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis 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.
Reason
Potential hardware issue which may cause thermal effects and possible damage to system parts.
Identifiers
| code_info | Model 10848280 - Serial Numbers: 103221 103061 103232 103217 103030 103218 103220 103013 103053 103039 10305…Model 10848280 - Serial Numbers: 103221 103061 103232 103217 103030 103218 103220 103013 103053 103039 103050 103008 103207 103222 103035 103230 103258 103001 103239 103263 103048 103028 103241 103212 103254 103255 103257 103245 103040 103253 Model 10848281 - Serial Numbers: 109033 109135 109141 109502 109123 109400 109344 109210 109080 109074 109417 109352 109388 109479 109418 109190 109191 109197 109198 109305 109405 109437 109119 109346 109419 109421 109016 109118 109493 109166 109496 109460 109137 109155 109379 109300 109187 109228 109327 109412 109066 109067 109068 109084 109133 109134 109365 109217 109366 109203 109011 109367 109169 109096 109159 109358 109202 109130 109490 109378 109384 109500 109451 109504 109505 109143 109431 109102 109445 109383 109407 109015 109211 109144 109413 109482 109332 109309 109488 109304 109168 109227 109467 109057 109221 109484 10 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2747-2018%22
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