Philips recalls Incisive CT Plus whole-body CT scanners model 728149 (OUS) due to potential image flipping causing misdiagnosis or extra radiation. Affected units may require rescan.
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
Philips is recalling its Incisive CT Plus whole-body CT scanners (model 728149) because they might produce flipped or reversed images. This could lead to misdiagnosis, incorrect treatment, or extra radiation exposure if a rescan is needed.
The CT scanner may produce images that are flipped or reversed. This could cause doctors to misdiagnose conditions, treat incorrectly, or require additional scans, increasing radiation exposure.
Healthcare facilities using the Philips Incisive CT Plus whole-body CT scanners model 728149 (OUS) are affected. Patients receiving scans on these systems may be at risk of misdiagnosis or additional radiation exposure.
Check for the model number 728149 on the scanner's label. The system was sold with the UDI-DI (01)00884838103474(21) and serial numbers starting with 530537, 554032, 554060, 554065, or 554078.
Reach out to Philips for assistance with the recall process.
The scanner may produce flipped or reversed images, which could lead to misdiagnosis, incorrect treatment, or additional radiation exposure if a rescan is required.
Contact Philips directly for guidance on the recall process and necessary steps.
Look for the model number 728149 on the scanner's label. Affected units have the UDI-DI (01)00884838103474(21) and serial numbers starting with 530537, 554032, 554060, 554065, or 554078.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1625-2023 — Philips Philips Hello, I own a Philips that is covered by recall Z-1625-2023 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.
