Philips recalls Spectral CT on Rails with software version 5.1.0 (model 728334) due to risk of gantry misalignment during scans, potentially causing incorrect scans or collisions. Affected units sold from 2020-2021.
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).
Philips is recalling Spectral CT on Rails machines with software version 5.1.0 because a button press during scans might cause the gantry to move unexpectedly. This could lead to scans being done in the wrong location or physical collisions with the user or medical equipment.
Pressing the IVC needle position button during scans can cause the gantry to move to an unexpected location. This might result in scans being performed at the wrong position or unintended motion causing collisions with the user or medical equipment.
Medical facilities using Philips Spectral CT on Rails with software version 5.1.0 (model 728334) are affected. Staff operating the equipment and patients undergoing scans are at risk of incorrect positioning or collisions.
Check for the model number 728334 and software version 5.1.0 on the device. Units were sold between 2020 and 2021 with UDI-DI: 00884838103627 and lot code 1005.
Verify the software version on your Spectral CT on Rails device; affected units have version 5.1.0.
Reach out to Philips North America for guidance on potential fixes or updates.
Philips is recalling these units because pressing the IVC needle position button during scans can cause the gantry to move unexpectedly, potentially leading to incorrect scans or collisions.
Check your software version; if it's 5.1.0, contact Philips North America for guidance on fixes or updates.
Yes, the recall states that unintended gantry motion could cause collisions with the user or medical equipment, but no specific injuries have been reported.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0319-2024 — Philips Philips Hello, I own a Philips that is covered by recall Z-0319-2024 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.
