FDA Device recall Z-1981-2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems
- 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 Bracket Assembly for use with CT and PET/CT systems 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-1981-2021 |
| 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 Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251 - Brilliance 10 728260 - Extended Brilliance Workspace
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 728240 60005 728240 60003 728240 6017 728240 60012 728240 60007 728240 6105 728240…Model/ Serial Number/UDI: N/A 728240 60005 728240 60003 728240 6017 728240 60012 728240 60007 728240 6105 728240 6136 728240 60016 728240 60014 728240 60006 728240 6156 728240 5080 728240 60011 728240 6109 728240 5413 728245 3371 728245 3394 728245 3484_ 728245 3500 728245 3377 728245 . 728245 3448 728245 3483 728245 3443 728245 3360 728245 9732 728245 3426 728245 3429 728245 6109 728245 3408 728245 3473 728245 3419 728246 260032 728246 6444 728246 6265 728246 5452 728246 40018 728246 6618 728246 50081 728246 50014 728246 50026 728246 6556 728246 5449 728246 50029 728246 5485 728246 5942 728246 50046 728246 30019 728246 5313 728246 5013 728246 50096 728246 5207 728246 5916 728246 50094 728246 30033 728246 50032 728246 5174 728246 6503 728246 6519 728246 6511 728246 5773 728246 5816 728246 260015 728246 6491 728246 5296 728246 50188 728246 30103 728246 5041 728246 4017 728246 5632 728246 50010 728246 5658 72824 |
|---|
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-1981-2021%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.