Galaxy System bronchoscope power supply defect may injure lung tissue
Noah Medical's Galaxy System bronchoscope has defective power supply semiconductors that may fail during procedures, potentially causing pneumothorax or lung tissue injury when the scope is manually removed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with potential risk of pneumothorax and lung tissue injury during instrument removal. No illnesses or injuries have been reported to date. Per the rubric, risk-of-harm products where injury has not yet been reported warrant a score of 3.
Plain-English summary
Noah Medical is recalling the Galaxy System (GAL-001) bronchoscopic visualization system due to defective semiconductor components in its power supply. These components may fail unexpectedly during patient procedures.
When the power supply fails, the failure is non-recoverable and the procedure must be aborted. Removing the bronchoscope manually while the system is non-functional increases the risk of injury to lung tissue, including the possibility of pneumothorax (collapsed lung).
A total of 18 systems have been recalled. The recalled serial numbers are CRB-1502, CRB-1503, CRB-1506, CRB-1508, CRB-1516, CRB-1517, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1527, CRB-1528, CRB-1529, CRB-1530, and CRB-1532. Medical facilities should contact Noah Medical about corrective actions.
The recalled product
- Product
- Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
- Manufacturer
- Noah Medical
- Category
- Medical Device — Bronchoscopy
- Affected units
- 18
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- UDI-DI: 00850048825048. Serial Numbers: CRB-1502
- CRB-1503
- CRB-1506
- CRB-1508
- CRB-1516
- CRB-1517
- CRB-1519
- CRB-1520
- CRB-1521
- CRB-1522
- CRB-1523
- CRB-1524
- CRB-1525
- CRB-1527
- CRB-1528
- CRB-1529
- CRB-1530
- CRB-1532
Distribution
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