Siemens recalls Artis zee, zeego, Q, and Q.zen models due to potential radiation levels exceeding safety limits when switching frame rates during fluoroscopy. Affected units may require repair or replacement.
When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.
Siemens is recalling several medical imaging devices because changing frame rates during fluoroscopy can cause radiation levels to exceed safety limits. This could lead to unnecessary radiation exposure for patients or staff if the device is used without correction.
When a user switches from lower to higher frame rates during continuous fluoroscopy (e.g., from 10 to 30 frames per second), the device may measure radiation levels that exceed regulatory safety limits. This could result in unnecessary radiation exposure for patients or medical staff.
Medical facilities using Siemens Artis zee, zeego, Q, or Q.zen models are likely affected. Staff and patients using these devices during procedures may be at risk if the device is not corrected.
Check for model numbers listed: Artis zee floor (10094135), ceiling (10094137), multi-purpose (10094139), biplane (10094141), zeego (10280959), Pheno (10849000), Q floor (10848280), ceiling (10848281), biplane (10848282), zeego (10848283), Q.zen floor (10848353), ceiling (10848354), biplane (10848355).
Identify your device model by checking the serial numbers listed in the recall notice.
The recall occurs because changing frame rates during continuous fluoroscopy can cause radiation levels to exceed regulatory safety limits.
The recall notice does not specify a remedy, so contact Siemens directly for guidance on next steps.
The recall states a risk of exceeding radiation limits, but the official notice does not mention serious injury or death as a direct hazard.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0656-2021 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0656-2021 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.
