Philips recalled 81 IQon Spectral CT systems on August 13, 2025, due to a potential fall hazard. The patient support table may descend unexpectedly due to a ball screw misalignment. Healthcare providers and patients must stop using the device immediately.
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
The recall affects IQon Spectral CT systems, Model Number: 728332. Serial numbers include 860088, 860023, 860077, and more. These systems were distributed worldwide, including the United States and 51 other countries.
The patient support table may descend unexpectedly to the lowest position, leading to potential injuries. This defect is attributed to a misalignment of the ball screw component.
As of now, there are no reported injuries related to this defect. The hazard presents a significant risk during patient procedures.
Stop using the affected device immediately. Follow the manufacturer's recall instructions and contact Philips North America or your healthcare provider for further guidance.
For inquiries, reach Philips North America at their official website or the recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2601-2025.
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