Brilliance 64 Computed Tomography X-ray system
This recall has been terminated (originally issued December 24, 2015).
- Recall Initiated
- October 29, 2015
- Posted
- December 24, 2015
- Terminated
- June 26, 2018
- Recall Number
- Z-0544-2016
- Quantity
- 30 units
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Model No. 728231; S/N: 4001, 9074, 9099, 9538, 9549, 9573, 9638, 9646, 9656, 9667, 9703, 9738, 9755, 9782, 9811, 9822, 9909, 9923, 9927, 9933, 10021, 10042, 10077, 10150, 10180, 10379, 29056, 29107, 29115, 90124, 90154, 95024, 95130, 95222, 95236, 95258, 95261, 95364, 95399, 95410, 95475, 95551, 95614, 95668, 95688 & 95691.
Root Cause
Software design
Action Taken
On 10/30/2015 the firm sent Customer Information letters to their Consignees.