FDA recall Z-1589-2023

Philips North America · Class II · device

Product

CombiDiagnost R90 R1.1

Reason for recall

Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

Distribution

US Nationwide

Key facts

Status: Ongoing
Initiation date: 2023-03-03
Report date: 2023-05-24
Voluntary/Mandated: FDA Mandated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1589-2023