Philips Healthcare Ingenuity Core128 X-Ray recall
Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional…
Why was Philips Healthcare Ingenuity Core128 X-Ray recalled?
During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software version 4.16
- Product
- Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional…
- Recalling firm
- Philips Electronics North America Corporation
- Quantity
- US- 606
- Distribution
- USA (nationwide) Distribution
- Recall date
- October 25, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)