FDA Device recall Z-1409-2018
Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce…
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce… by Philips Medical Systems Cleveland, citing closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1409-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-08 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Reason
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Identifiers
| code_info | Serial No : 200205 200203 200210 200213 200208 200204 200212 200201 200206 200207 200209 200215 83001 2002…Serial No : 200205 200203 200210 200213 200208 200204 200212 200201 200206 200207 200209 200215 83001 200200 200202 200200 200043 200211 200214 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1409-2018%22
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