Philips recalled three Ingenuity CT Family systems on August 13, 2025, due to a hazard that could lead to sudden descent. The issue stems from a ball screw misalignment affecting the patient support table. Users should stop using the devices immediately and follow 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 recall involves Ingenuity CT Family systems, Model Number 728325. The affected serial numbers are 338014, 338028, and 338019. These devices were distributed worldwide, including the US and several other countries.
The patient support table may descend unexpectedly to the lowest position, posing a risk of injury. This issue arises from a component misalignment after replacement.
No injuries or incidents have been reported related to this recall. The risk remains significant due to the potential for unexpected descents.
Stop using the affected devices immediately. Contact Philips North America or your healthcare provider for further instructions regarding the recall.
For more information, visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2603-2025.
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