FDA recall Z-2289-2021

Product

Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B

Reason for recall

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

Distribution

Worldwide distribution - US nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2021-07-26

Report date

2021-08-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Murrysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2289-2021