Siemens recalls its Biograph Horizon 3R Mobile CT scanners due to potential PET gantry locking mechanism failure. Affected units have specific UDI/DI and serial numbers. No remedy is provided in the recall notice.
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
Siemens is recalling certain Biograph Horizon 3:R Mobile CT scanners because of a potential issue with the locking mechanism that secures the PET gantry. This could lead to the gantry not staying in place during scanning or service, potentially causing safety risks. The recall does not include a remedy, so affected owners should contact Siemens directly for guidance.
The locking mechanism that secures the PET gantry in either scanning or service positions may fail, causing the gantry to move unexpectedly. This could lead to the scanner not staying in place, potentially causing injury to patients or staff during procedures.
Medical facilities that own or use the recalled Siemens Biograph Horizon 3R Mobile CT scanners are most at risk. Patients and staff using these scanners could be affected if the locking mechanism fails during procedures.
Check for the UDI/DI number 405686901102894792 and serial number 94792 on the scanner's label. The product is a Siemens Biograph Horizon 3R Mobile CT scanner used for medical imaging.
Reach out to Siemens Medical Solutions USA, Inc. directly for specific guidance on handling the recalled scanner.
The recall notice does not provide a remedy, so no fix is available at this time.
Check for the UDI/DI number 405686901102894792 and serial number 94792 on the scanner's label.
Contact Siemens Medical Solutions USA, Inc. directly for specific guidance on handling the recalled scanner.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1134-2023 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1134-2023 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.
