FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Whole body Computed Tomography X-Ray System (Brilliance 64 and Ingenuity CT), Brilliance 64 M/N 728231, Ingenuity CT M/N 728326, Dist. By Philips Medical Systems, Cleveland, OH
- Recall number
- Z-1285-2012
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Whole body Computed Tomography X-Ray System (Brilliance 64 and Ingenuity CT), Brilliance 64 M/N 728231, Ingenuity CT M/N 728326, Dist. By Philips Medical Systems, Cleveland, OH
- Status
- Terminated
- Initiated
- 2012-02-17
- Posted
- 2012-03-23
- Terminated
- 2013-02-22
- Reason
- A number of non-conformances were identified during internal and external validation testing of the Brilliance 64 and Ingenuity CT systems with software version Beta 3 (version 4.0.0.xx368).
- Root cause
- Software change control
- Action
- Philips Healthcare sent an Urgent Medical Device Correction letter dated February 17, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of the contents in the communication. Customers were asked to retain a copy of the communication with the equipment instruction for Use. For further information or support concerning this issue, customers should contact their local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center at 1-800-722-9377, option 5. For questions regarding this recall call 440-483-7000.
- Quantity
- 7 units
- Distribution
- Worldwide Distribution - USA including OH and the following countries: Australia, China, Belgium, Israel & Sweden.
- Lot, serial or model codes
- System Code # 728231, Serial # 91003, 95130, 95157, 95504 & 300030; System Code # 728326, Serial # 300010 & 300018.
- 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