Home / Recalls / Noah Medical / Z-0693-2025

Z-0693-2025 Class II Ongoing

Recalled by Noah Medical — San Carlos, CA

Recall Details

Product Type
Devices
Report Date
December 25, 2024
Initiation Date
October 25, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
26

Product Description

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 Pattern

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

Code Information

UDI-DI: 00850048825048. Serial Numbers: CRB-1502, CRB-1503, CRB-1508, CRB-1513, CRB-1514, CRB-1515, CRB-1516, CRB-1518, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1528, CRB-1530, CRB-1532, CRB-1534, CRB-1535, CRB-1537, CRB-1538, CRB-1540, CRB-1541, CRB-1543, CRB-1554

Other recalls by Noah Medical

  • Z-0742-2025 Class II — Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and (October 28, 2024)
  • Z-0679-2025 Class II — Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 100 (October 25, 2024)
  • Z-1734-2024 Class II — Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy (March 9, 2024)