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 airways for diagnostic and therapeutic procedures.
Reported: May 8, 2024 Initiated: March 9, 2024 #Z-1734-2024
Product Description
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 airways for diagnostic and therapeutic procedures.
Reason for Recall
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Details
- Recalling Firm
- Noah Medical
- Units Affected
- 17 wired controllers
- Distribution
- U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
- Location
- San Carlos, CA
Frequently Asked Questions
What product was recalled? ▼
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 airways for diagnostic and therapeutic procedures.. Recalled by Noah Medical. Units affected: 17 wired controllers.
Why was this product recalled? ▼
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2024. Severity: Moderate. Recall number: Z-1734-2024.
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