Siemens recalls specific COHERENCE Oncologist models with software versions 2.0.49-2.0.51 due to potential incorrect patient repositioning and radiation dose risks.
A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the patient and dose to wrong location.
Siemens is recalling two specific models of COHERENCE Oncologist medical imaging devices that have software versions 2.0.49 through 2.0.51. These devices could misalign patient positioning after certain software operations, potentially causing incorrect radiation doses to the wrong body areas.
When the device performs an offset calculation followed by a filter operation, it can misalign the patient's position. This misalignment may cause radiation to be delivered to the wrong body area, potentially increasing radiation exposure to unintended tissues.
Healthcare facilities using Siemens COHERENCE Oncologist models with software versions 2.0.49 through 2.0.51 are most at risk. Patients undergoing radiation treatments with these devices may experience incorrect positioning.
Check if your COHERENCE Oncologist device has model numbers 07333680 or 07351898 and software versions 2.0.49 through 2.0.51. These specific versions were identified in the recall notice.
Verify your device's software version by checking the device settings or documentation. The affected versions are 2.0.49 through 2.0.51.
Reach out to Siemens Medical Solutions USA, Inc for guidance on potential fixes or updates to address the software issue.
The recall occurs because a specific software sequence can cause incorrect patient repositioning and radiation dose errors, potentially leading to unintended radiation exposure.
Check your device's software version. If it's 2.0.49 through 2.0.51, contact Siemens for guidance on updates or fixes.
The recall addresses potential incorrect radiation dosing, but the official notice does not specify a risk of serious injury or death.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1346-2020 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1346-2020 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.
