Philips Healthcare recalls Incisive CT models 728143 & 728144 with software version 5.0.0 due to potential misdiagnosis from image artifacts and incorrect labels. Affected units may require rescan or correction.
Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.
Philips Healthcare is recalling two specific CT scanner models with software version 5.0.0 because software issues could cause misdiagnosis through image artifacts or incorrect labels. This affects medical imaging accuracy and may require additional scans.
The software issues can cause image artifacts, incorrect orientation labels, or failure to display images properly. This may lead to misdiagnosis or the need for additional scans, but does not pose an immediate physical danger to users.
Healthcare facilities using Philips Incisive CT scanners with model numbers 728143 or 728144 and software version 5.0.0 are most at risk. Medical staff and patients using these scanners could experience misdiagnosis.
Check if your Philips Incisive CT scanner has model numbers 728143 or 728144 and software version 5.0.0. The unique device identifiers (UDI-DI) are 00884838085015 for model 728143 and 00884838105508 for model 728144.
Verify your scanner's software version by checking the device settings or documentation. If it is version 5.0.0, it is affected.
The recall is due to multiple software issues that could cause misdiagnosis through image artifacts or incorrect labels, requiring potential rescan or correction.
Check your scanner's software version. If it is 5.0.0, contact Philips Healthcare to confirm if a fix is needed.
No immediate physical risks are reported; the issue relates to potential misdiagnosis, not direct harm to users.
We’ve drafted a message you can send Philips Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0640-2024 — Philips Healthcare Philips Healthcare Hello, I own a Philips Healthcare that is covered by recall Z-0640-2024 from Philips Healthcare. 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.
