Noah Medical recalls Galaxy System REF GAL-001 (specifically GAL-019 wired controller) due to misaligned calibration causing unintended scope motion. Affected units have serial numbers starting with GWC.
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Noah Medical is recalling specific Galaxy System wired controllers (model GAL-019) because a calibration issue might cause the scope to move unexpectedly during medical procedures. This could lead to unintended patient interactions if the scope moves without user control.
The wired controller's calibration is misaligned, which can cause the scope to move unexpectedly during use. This unintended motion might interfere with the procedure and potentially cause patient discomfort or complications if not properly controlled.
Medical professionals using the Galaxy System for airway procedures are most at risk. Patients undergoing bronchoscopic procedures with the recalled controllers may experience unintended scope movement.
Check for serial numbers starting with GWC (e.g., GWC-1529, GWC-1538). The specific model is GAL-019, part of Galaxy System REF GAL-001. The product was sold with the UDI-DI code 00850048825048.
Look for serial numbers starting with GWC on the controller's label.
Reach out to Noah Medical for further instructions if you have the recalled controller.
The wired controller has a misaligned calibration that may cause unintended motion of the scope during medical procedures.
The Galaxy System REF GAL-001 with wired controller model GAL-019.
Check for serial numbers starting with GWC (e.g., GWC-1529, GWC-1538).
We’ve drafted a message you can send Noah Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1734-2024 — Noah Medical Noah Medical Hello, I own a Noah Medical that is covered by recall Z-1734-2024 from Noah Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.