FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Brilliance 64 Computed Tomography X-ray system
- Recall number
- Z-0544-2016
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Brilliance 64 Computed Tomography X-ray system
- Status
- Terminated
- Initiated
- 2015-10-29
- Posted
- 2015-12-24
- Terminated
- 2018-06-26
- Reason
- 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.
- Root cause
- Software design
- Action
- On 10/30/2015 the firm sent Customer Information letters to their Consignees.
- Quantity
- 30 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K033326"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28