Siemens recalls ARTIS Pheno Interventional Fluoroscopic X-Ray System Model 10849000 due to potential patient injury from C-arm drop when manually extended.
If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.
Siemens is recalling its ARTIS Pheno Interventional Fluoroscopic X-Ray System (Model 10849000) because moving the C-arm to full extension can cause it to drop up to 20 mm, potentially injuring patients. This could require stopping treatment or switching to another system.
If the C-arm is manually moved to full extension, the safety stop mechanism may activate, causing the C-arm to drop up to 20 mm. This drop could cause the detector or collimator cover to touch the patient, potentially leading to injury.
Healthcare providers using the ARTIS Pheno Interventional Fluoroscopic X-Ray System Model 10849000 are affected. Patients undergoing procedures with this system are at risk of injury from the C-arm drop.
Check for the ARTIS Pheno Interventional Fluoroscopic X-Ray System with model number 10849000. This model was sold in the U.S. between 2019 and 2020 based on the serial numbers listed.
Ensure the C-arm is not manually moved to full extension before use.
Watch for the C-arm dropping up to 20 mm during operation, which could cause patient injury.
Yes, the C-arm can drop up to 20 mm when manually extended, potentially causing patient injury.
Check for the ARTIS Pheno Interventional Fluoroscopic X-Ray System with model number 10849000, which was sold between 2019 and 2020.
No, but you should avoid manually extending the C-arm to full position and monitor for drops.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2283-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2283-2018 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.
