FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
- Recall number
- Z-0360-2012
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
- Status
- Terminated
- Initiated
- 2011-09-06
- Posted
- 2011-12-02
- Terminated
- 2013-03-15
- Reason
- Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64 and Ingenuity CT software version 4.0 Beta 2. The non-conformances are due to software errors identified in these device systems.
- Root cause
- Software design
- Action
- Philips Healthcare released a 'Field Change Order' (FCO #72800542) on September 15, 2011. Philips sent an URGENT - Medical Device Correction letter dated October 10, 2011, to all affected customers. The letter listed the affected device systems; described the nature of the software problem; and any possible hazard inherent to the situation. The letter was mailed by Philips to their customers on October 27, 2011. The letter provided information telling the customer how to identify the affected products and what action to take. In this instance, the customer was asked to review the Customer Release Notes which were provided to each customer location once the software update was installed. The letter notified the customer that a Philips representative would be installing a software upgrade in order to address the referenced software issues free-of-charge, through a Field Change Order. The letter closes by providing information which all customers in Canada and North America can use to contact the firm through a toll-free telephone number 1-800-722-9377, option 5; enter side ID or follow the prompts. For questions regarding this recall call 440-483-4918.
- Quantity
- 5 units
- Distribution
- Worldwide Distribution - USA including Ohio and the countries of Australia, China, Belgium, Israel, and Sweden
- Lot, serial or model codes
- Model #728231, 510(k) #KK033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157.
- 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