FDA Device recall Z-2748-2018
ARTIS Pheno Model 10849000
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of ARTIS Pheno Model 10849000 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-2748-2018 |
| 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 Pheno Model 10849000. Interventional Fluoroscopic X-Ray System 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 | Serial Numbers: 164033 164071 164034 164095 164057 164054 164055 164080 164072 164088 164048 164094 164068…Serial Numbers: 164033 164071 164034 164095 164057 164054 164055 164080 164072 164088 164048 164094 164068 164019 164013 164073 164025 164026 164027 164060 164083 164113 164021 164066 164075 164074 164084 164086 164098 164028 164053 164063 164064 164105 164024 164049 164018 164022 164061 164115 164100 164097 164011 |
|---|
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-2748-2018%22
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