FDA recall Z-0693-2025

Product

Galaxy System (GAL-001)

Reason for recall

Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.

Distribution

US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY

Key facts

Status

Ongoing

Initiation date

2024-10-25

Report date

2024-12-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Carlos, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0693-2025