Noah Medical: Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airw

Hazard

Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.

Details from the source

Reason for recall: Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope. Distribution: U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA. Quantity: 17 wired controllers Lot/code info: Model Number: GAL-001 Wired Controller Model Number: GAL-019 UDI-DI code: 00850048825048 (additional information pending) Serial Numbers: GWC-1529 GWC-1538 GWC-1541 GWC-1576 GWC-1579 GWC-1560 GWC-1566 GWC-1586 GWC-1590 GWC-1581 GWC-1589 GWC-1552 GWC-1572 GWC-1547 GWC-1571 GWC-1564 GWC-1537

UPC codes

00850048825048

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.