Philips recalled 3 Ingenuity CT Family Brazil systems, Model 728325, distributed worldwide, including the United States. A ball screw misalignment after a replacement may cause the patient support table to descend to the lowest position. Hospitals and clinicians should stop using the device and follow Philips recall instructions.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America Llc or your healthcare provider for instructions. Notification method: Letter
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The Ingenuity CT Family Brazil CT system is used for diagnostic medical imaging. Model 728325 and its serials were part of a limited recall due to a mechanical misalignment.
A ball screw misalignment after a replacement can cause the patient support couch to descend unexpectedly to the lowest position, posing a risk to patient safety.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics with affected units must halt use and arrange service per recall instructions. The recall involves three units in global distribution, potentially impacting patient procedures and workflow.
Refer to the FDA enforcement recall page and Philips recall notices. Device labels list model and serial numbers.
No timeline is specified for replacement or repair in the recall notice.
Keep the recall letter, note serial/model numbers, capture photos of device labels, and preserve all correspondence with Philips and healthcare providers.
Model Number: 728325; Serial Numbers: 338014, 338028, 338019; Where Sold: Worldwide distribution including US; When Sold: Unknown; Price: Unknown.
No injuries or incidents have been reported.
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