Philips recalls Spectral CT on Rails with software version 5.1.0.X (model 728334) due to potential misdiagnosis from incorrect image labeling. Affected units may require software update to prevent incorrect treatment.
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Philips is recalling Spectral CT on Rails machines with software version 5.1.0.X (model 728334) because a software issue could cause images to be mislabeled, leading to wrong medical treatments. This affects hospitals and clinics using the equipment.
The software issue causes captured medical images to be incorrectly labeled, which could lead to misdiagnosis and inappropriate medical treatments. This happens because the software fails to properly process image data during scans.
Hospitals and clinics that purchased or use Philips Spectral CT on Rails with software version 5.1.0.X (model 728334) are affected. Medical staff and patients using the equipment may be at risk of incorrect treatment.
Check for the model number 728334 and software version 5.1.0.X on the device. The UDI-DI is 00884838103627 and serial number is 1005.
Verify the software version on the device; if it is 5.1.0.X, it is affected.
The affected software version is 5.1.0.X.
Check for model number 728334 and software version 5.1.0.X on the device. The UDI-DI is 00884838103627 and serial number is 1005.
No immediate stop is required; affected units can continue use after updating the software.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1054-2024 — Philips Philips Hello, I own a Philips that is covered by recall Z-1054-2024 from Philips. 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.
