Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option — Class II medical device recall Z-1980-2021
Ongoing recall by Philips North America Llc, reported 2021-07-07, distributed nationwide. Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor
| Recall number | Z-1980-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2021-05-01 |
| Classified | 2021-06-30 |
| Reported by FDA | 2021-07-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 1,301 monitor |
| Reason classes | device malfunction |
| Model numbers | 728131 |
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1980-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.