FDA Device recall Z-1984-2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuit…
- 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 Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuit… 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-1984-2021 |
| 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 Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
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 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT…Model/ Serial Number/UDI: N/A 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT 728321 52051 N/A 728321 52113 (01)00884838059498(21)52113 728321 52105 (01)00884838059498(21)52105 728321 52106 (01)00884838059498(21)52106 728321 333121 N/A 728321 52018 N/A 728321 310113 N/A 728321 310114 N/A 728321 310128 N/A 728321 310162 N/A 728321 333024 N/A 728321 52159 (01)00884838059498(21)52159 728321 52129 N/A 728321 333078 N/A 728321 52079 N/A 728321 52052 N/A 728321 333057 N/A 728321 333059 N/A 728321 941164 N/A 728321 333132 N/A 728321 333146 N/A 728321 30025 N/A 728321 333043 N/A 728321 333150 N/A 728321 333071 N/A 728321 52110 (01)00884838059498(21)52110 728321 333159 (01)00884838059498(21)333159 728321 52020 N/A 728321 310063 N/A 728321 310141 N/A 728321 310133 N/A 728321 52153 (01)00884838059498(21)52153 728321 333151 N/A 728321 333060 N/A 728321 310377 (01)00884838059498(21)310377 728321 333094 N/A 728321 310059 N/ |
|---|
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-1984-2021%22
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