FDA Device recall Z-2709-2014
Brilliance CT System 6/10/16/16P/40 configuration
- FDA Device
- Class II
- terminated
- Published 2014-10-01
On 2014-10-01 the FDA classified a Class II recall of Brilliance CT System 6/10/16/16P/40 configuration by Philips Medical Systems Cleveland, citing the system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2709-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2005-12-27 |
| Published | 2014-10-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, WI |
Product
Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.
Reason
The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.
Identifiers
| code_info | 728256, 728251, 728246, 728240, and 728235. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2709-2014%22
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