FDA recall Z-1281-2021

RAYSEARCH LABORATORIES AB · Class II · device

Product

RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.

Reason for recall

Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later

Distribution

US Nationwide distribution in the state of TN.

Key facts

Status
Ongoing
Initiation date
2021-03-03
Report date
2021-03-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1281-2021