FDA recall Z-0248-2020

Product

SAROS Oxygen System Model 3000

Reason for recall

There is an electronics control issue that causes the unit to not power on with battery power only.

Distribution

US and Chile

Key facts

Status

Terminated

Initiation date

2019-09-16

Report date

2019-11-06

Termination date

2020-12-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ball Ground, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0248-2020