Galaxy System Wired Controller Recalled for Unintended Scope Motion
Noah Medical recalls 17 Galaxy System wired controllers (Model GAL-019) due to calibration misalignment that may cause unintended scope motion during bronchoscopic procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall without reported injuries or illnesses. The hazard—calibration misalignment causing unintended scope motion during airway procedures—represents a risk-of-harm scenario where injury has not yet been reported, meeting the Score 3 (High) criterion.
Plain-English summary
Noah Medical has recalled 17 Galaxy System wired controllers (Model GAL-019). These devices are intended to provide visualization and access to patient airways for diagnostic and therapeutic bronchoscopic procedures.
The recall is due to misaligned calibration of the wired controller that may result in unintended motion of the scope during use. This potential malfunction could compromise the safety and effectiveness of the procedure.
The affected units were distributed nationwide in California, Indiana, Maryland, Missouri, Ohio, and Pennsylvania. The recalled serial numbers are: 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, and GWC-1537.
The recalled product
- 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.
- Manufacturer
- Noah Medical
- Affected units
- 17
Distribution
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