FDA recall Z-2097-2019

Product

Burstberry Laser Projection Series

Reason for recall

The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.

Distribution

Unknown

Key facts

Status

Ongoing

Initiation date

2019-07-10

Report date

2019-08-14

Voluntary/Mandated

FDA Mandated

Location

Glendale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2097-2019