FDA Medical Device Recalls (openFDA)
Philips North America Llc: BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
- Recall number
- Z-1774-2021
- Recalling firm
- Philips North America Llc
- Product
- BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
- Status
- Terminated
- Initiated
- 2021-04-13
- Posted
- not on file
- Terminated
- 2022-09-23
- Reason
- Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
- Root cause
- Under Investigation by firm
- Action
- Philips Regional Service Manager spoke to Customer on 13 April 2021, and advised them to stop use of the product until repair could be completed and followed communication by email. On 14-Apr-2021 component was replaced and system returned to service.
- Quantity
- 2 units (1 US and 1 OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.
- Lot, serial or model codes
- Serial Numbers: 100100, 100434
- 510(k) numbers
- ["K060937"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3016618143
- Firm city
- Cambridge
- Firm state
- MA
- 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