FDA Device recall Z-1979-2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX800…
- 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: Model - MX800… 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-1979-2021 |
| 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: Model - MX8000 Models: 728120/728125/728201
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: 728120 2516 N/A 728120 3179 N/A 728120 3316 N/A 728201 9326 N/A 728120 3304 N/A 728120…Model/ Serial Number/UDI: 728120 2516 N/A 728120 3179 N/A 728120 3316 N/A 728201 9326 N/A 728120 3304 N/A 728120 3271 N/A 728120 2537 N/A 728120 3324 N/A 728120 H3321 N/A 728120 3058 N/A 728125 2529 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-1979-2021%22
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