Ingenuity CT Computed Tomography X-ray system recall: Software Issue
Ingenuity CT Computed Tomography X-ray system
Why was Ingenuity CT Computed Tomography X-ray system recalled?
Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
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?
Model No. 728326; S/N: 2, 1234, 30005, 30009, 30017, 30018, 30020, 30023, 30028, 30031, 30034, 30037, 31001, 32065, 32067, 52030, 52031, 52044, 52049, 52050, 300159, 300204, 300205, 300207, 300208, 300209, 310002, 310003, 333057, 333064 & 336061.
- Product
- Ingenuity CT Computed Tomography X-ray system
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 31 Units
- Distribution
- Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
- Recall date
- December 30, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)