Philips recalled 14 Brilliance iCT SP CT systems, model 728311, sold worldwide including the United States. The patient support couch may descend unexpectedly to the lowermost position because of ball screw misalignment after a replacement. Hospitals should stop using the device immediately and await manufacturer 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 Brilliance iCT SP CT System is a diagnostic imaging platform used by hospitals for CT scans. It combines advanced imaging with patient support equipment used during procedures.
A misalignment in the ball screw after a replacement can cause the patient couch to descend unexpectedly, potentially injuring a patient during a scan or repositioning.
This recall is not described as part of a broader industry pattern in the available notice.
The hazard creates immediate safety concerns for patients and healthcare staff. Hospitals must halt use of affected units and coordinate with Philips for remediation.
Refer to the FDA enforcement page linked in the notice and Philips recall communications for device identifiers.
Remediation steps will be provided by Philips. Timelines vary by facility and replacement parts availability.
Keep the recall letter, model/serial numbers, and all correspondence with Philips and your hospital’s biomedical team.
Brand: Philips Product: Brilliance iCT SP CT System Model numbers included: 728311 and related models Related models listed in recall: 200016, 200024, 200211, 200041, 200030, 200060, 200048, 200069, 200098, 200097, 200112, 200136, 200200, 200209 Quantity recalled: 14 units Where sold: Worldwide distribution including the US and numerous countries Sold since: Unknown Price: Unknown
No injuries or incidents have been reported.
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