Philips recalled 24 CT systems worldwide after finding that the patient support couch may descend unexpectedly following a replacement. The defect involves a misaligned ball screw in the couch mechanism. Hospitals and imaging centers should stop using the device immediately 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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CT scanners are used in medical imaging to produce detailed internal body images. The Ingenuity Core128 / Elite China labeling refers to a Philips model used in clinical settings.
The danger arises from a misaligned ball screw in the couch mechanism that can allow the patient table to descend suddenly after a replacement.
This recall is not described as part of a broader industry pattern in the notice.
Hospitals and imaging centers may need to halt procedures using affected units until inspected or repaired, potentially impacting scheduling and patient throughput.
Serial numbers and UDI are on the device label and in the recall notice. The recall page provides additional identification details.
Not specified in recall notice.
Keep copies of the recall letter, device label, serial numbers, and all correspondence with Philips and hospital risk management.
Model: Ingenuity Core128 / Elite China, Model Number: 728324. UDI-DI: 00884838059863. Serial Numbers: 336821, 337127, 336823, 336824, 336828, 336817, 336952, 336826, 336847, 336857, 336876, 336894, 336948, 336936, 336947, 337012, 337074, 337090. Quantity: 24 units. Distribution: Worldwide, including US nationwide and the countries listed in the recall notice. Country of origin: China for the Elite China labeling. Status: Active. Hazard: The patient support couch may descend unexpectedly to the lowermost position due to ball screw misalignment after a replacement. Remedy: Stop using the device.
No injuries or incidents have been reported.
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