FDA Device recall Z-1982-2021
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-1982-2021 |
| 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 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Brilliance 64 728317/728318 - Ingenuity Flex
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 728235 90040 728235 90191 728235 90192 728235 90061 728235 29090 728235 90111 7282…Model/ Serial Number/UDI: N/A 728235 90040 728235 90191 728235 90192 728235 90061 728235 29090 728235 90111 728235 29042 728235 90165 728235 29082 728235 29152 728235 90054 728235 90087 728235 90122 728235 90142 728235 90104 728235 90075 728235 9237 728235 90110 728235 90084 728235 90208 728235 9047 728235 90125 728235 90171 728235 90212 728235 90056 728235 90227 728235 90164 728235 90051 728235 90035 728231 9367 728231 95709 728231 10625 728231 10379 728231 9900 728231 10630 728231 10755 728231 10758 728231 90094.. 728231 9524 728231 95443 728231 95463 728231 90046 728231 95706 728231 95305 728231 10139 728231 29086 728231 10273 728231 95046 728231 95044 728231 95324 728231 90180 728231 95062 728231 95155 728231 95206 728231 95122 728231 95159 728231 90199 728231 95434 728231 95717 728231 95328 728231 95401 728231 10393 728231 90154 728231 95365 728231 95457 728231 95054 728231 95267 728231 95156 728231 95515 7282 |
|---|
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-1982-2021%22
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