Philips recalls Incisive CT Power whole-body CT scanners model 728148 (OUS) due to potential image flipping causing misdiagnosis or extra radiation. Affected units may need correction.
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 Power whole-body CT scanners with model number 728148 (OUS) because images might be flipped or reversed, leading to misdiagnosis or extra radiation exposure. This could cause incorrect treatment or the need for additional scans.
The CT scanner may produce images that are flipped or reversed, which could lead to misdiagnosis. This might result in incorrect treatment or the need for additional scans, increasing radiation exposure.
Healthcare facilities using Philips Incisive CT Power scanners with model number 728148 (OUS) are affected. Patients receiving scans on these units may be at risk of misdiagnosis or unnecessary radiation exposure.
Check for model number 728148 (OUS) on the scanner. The unit may also have a UDI-DI code (01)00884838103467 and serial number 102342065.
Check the model number on the scanner to confirm it is 728148 (OUS).
The scanner may produce images that are flipped or reversed, which could lead to misdiagnosis or unnecessary radiation exposure.
The official recall notice does not specify a remedy for healthcare facilities.
Check for model number 728148 (OUS) on the scanner, along with UDI-DI code (01)00884838103467 and serial number 102342065.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1624-2023 — Philips Philips Hello, I own a Philips that is covered by recall Z-1624-2023 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.
