Recall Z-1734-2024— Noah Medical
Class II · Ongoing
Class II FDA medical device recall by Noah Medical, initiated 2024-03-09. It names one FDA 510(k) clearance: K223144. Product: 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: Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope..
- Recalling firm
- Noah Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-09
- Firm location
- San Carlos, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.