FDA Device recall Z-1990-2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
- FDA Device
- Class II
- ongoing
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class II recall of Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP by Philips North America, citing significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in pot….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1990-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-01 |
| Published | 2021-07-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
Reason
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
Identifiers
| code_info | Model/ Serial Number/UDI: N/A System Code System Serial Number Unique Device Identifier (UDI#) 728306 100788 N/A 728…Model/ Serial Number/UDI: N/A System Code System Serial Number Unique Device Identifier (UDI#) 728306 100788 N/A 728306 100857 (01)00884838059474(21)100857 728306 100739 N/A 728306 100394 N/A 728306 100625 N/A 728306 100664 N/A 728306 100764 (01)00884838059474(21)100764 728306 100280 N/A 728306 100782 (01)00884838059474(21)100782 728306 100830 (01)00884838059474(21)100830 728306 100410 N/A 728306 100413 N/A 728306 100788 N/A 728306 100322 N/A 728306 100374 N/A 728306 100327 N/A 728306 100463 N/A 728306 85033 N/A 728306 85104 N/A 728306 85125 (01)00884838059474(21)85125 728306 85095 (01)00884838059474(21)85095 728306 85018 N/A 728306 85013 N/A 728306 100400 N/A 728306 100402 N/A 728306 100405 N/A 728306 100509 N/A 728306 100331 N/A 728306 100375 N/A 728306 100056 N/A 728306 85019 N/A 728306 100657 N/A 728306 100415 N/A 728306 100507 N/A 728306 100450 N/A 728306 100386 N/A 728306 85113 (01)00884838059474(21)85113 728306 100281 N/A 728306 100441 N/A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1990-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.