Ingenuity CT Computed Tomography X-ray system
Reported: December 30, 2015 Initiated: October 29, 2015 #Z-0549-2016
Product Description
Ingenuity CT Computed Tomography X-ray system
Reason for Recall
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.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 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.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Ingenuity CT Computed Tomography X-ray system. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 31 Units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2015. Severity: Moderate. Recall number: Z-0549-2016.
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