FDA recall Z-1416-2023

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

Product

SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

Reason for recall

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-02-20
Report date
2023-04-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Best, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1416-2023