728327 Ingenuity CT Upgrades-Computed Tomography X-ray recall: Software Issue
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Why was 728327 Ingenuity CT Upgrades-Computed Tomography X-ray recalled?
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for 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?
Serial Number: 300099 300106 300143 Software Version 4.1.10 SynchRight Option
- Product
- 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
- Recalling firm
- Philips North America Llc
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
- Recall date
- August 25, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)