FDA recall Z-2587-2023

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · device

Product

Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems

Reason for recall

A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.

Distribution

Worldwide distribution

Key facts

Status
Ongoing
Initiation date
2023-08-15
Report date
2023-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Best, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2587-2023