Siemens recalls ARTIS Pheno Interventional Fluoroscopic X-Ray System (Model 10849000) due to potential temperature control failure when unpowered for long periods.
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
Siemens is recalling its ARTIS Pheno Interventional Fluoroscopic X-Ray System (Model 10849000) because the temperature control unit may malfunction when the device is left powered down for extended periods, potentially causing the detector to exit its designed temperature range.
The temperature control unit may not function correctly when the system is unpowered for long periods, such as overnight. This could cause the detector to operate outside its designed temperature range, potentially affecting imaging quality but not causing immediate injury.
Healthcare facilities using the ARTIS Pheno Interventional Fluoroscopic X-Ray System (Model 10849000) are likely affected. Medical staff and patients using this equipment during procedures are at risk if the temperature issue occurs.
Check for the ARTIS Pheno Interventional Fluoroscopic X-Ray System with model number 10849000. This model was sold under the serial numbers 164013 and 164011.
Verify the model number on your device; affected units have model number 10849000.
The temperature control unit may malfunction when the system is unpowered for long periods, causing the detector to exit its designed temperature range.
The recall record does not specify a remedy or fix.
Check for the ARTIS Pheno Interventional Fluoroscopic X-Ray System with model number 10849000, which was sold with serial numbers 164013 and 164011.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-3190-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-3190-2018 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
