FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
- Recall number
- Z-2176-2018
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
- Status
- Terminated
- Initiated
- 2018-03-30
- Posted
- not on file
- Terminated
- 2020-04-14
- Reason
- The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
- Root cause
- Device Design
- Action
- Urgent Field Safety Notices dated 3/28/18 were distributed to customers. The letters instructed customers to perform the following actions: Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. Please retain a copy with the equipment Instruction for Use. As outlined in the Instructions for Use, always monitor the patient during all movements (manual or motorized) of the patient support. If you recognize an impending collision with the back shelter wall, halt the motion or activate the system E-stop. Mandatory Field Change Order (FCO) 72800686 which will add additional warning labels specific to this issue to the system. The FCO will be implemented free of charge.
- Quantity
- 20
- Distribution
- Worldwide distribution including US states of CA, MD, NV, OH, TX, and WI, Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon.
- Lot, serial or model codes
- System Serial Numbers: 5380, 5379, 5520, 5524, 5538, 5539, 5549, 5779, 5792, 5778, 5808, 5887, 5888, 5973, 6020, 6026, 6110, 6097, 6352, 6424
- 510(k) numbers
- ["K012009"]
- 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