Bronchoscopic system may lose power due to defective component
A defective power component in Noah Medical's Galaxy System bronchoscope may cause sudden power loss during procedures, potentially leading to lung injury or pneumotharax.
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 recall of a medical device with potential to cause serious patient harm (lung injury, pneumotharax) if power failure occurs during a procedure. However, no illnesses or injuries have been reported in the source documentation, making this a theoretical risk-of-harm scenario that warrants a High severity score rather than Severe.
Plain-English summary
Noah Medical's Galaxy System (GAL-001) bronchoscope is subject to recall due to a defective component in its uninterruptable power system. The defect may cause the power supply to short circuit or trip protective circuit breakers, resulting in sudden and unrecoverable power loss.
If power loss occurs while the system is operating during a procedure, the bronchoscope may be interrupted or aborted abruptly. Manual removal of the device may become necessary, which could lead to lung injury or pneumotharax.
The recall affects 26 Galaxy System units distributed to healthcare facilities in 16 states: California, Massachusetts, Pennsylvania, New Jersey, Idaho, Connecticut, Missouri, North Carolina, Maryland, Illinois, Tennessee, Virginia, Ohio, Indiana, West Virginia, and New York. Affected units can be identified by their serial numbers: CRB-1502, CRB-1503, CRB-1508, CRB-1513, CRB-1514, CRB-1515, CRB-1516, CRB-1518, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1528, CRB-1530, CRB-1532, CRB-1534, CRB-1535, CRB-1537, CRB-1538, CRB-1540, CRB-1541, CRB-1543, CRB-1554.
Healthcare facilities should immediately discontinue use of affected units and contact Noah Medical for corrective action or replacement.
The recalled product
- Product
- Galaxy System (GAL-001)
- Manufacturer
- Noah Medical
- Category
- Medical Device — Bronchoscope
- Affected units
- 26
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 (20)
- UDI-DI: 00850048825048. Serial Numbers: CRB-1502
- CRB-1503
- CRB-1508
- CRB-1513
- CRB-1514
- CRB-1515
- CRB-1516
- CRB-1518
- CRB-1519
- CRB-1520
- CRB-1521
- CRB-1522
- CRB-1523
- CRB-1524
- CRB-1525
- CRB-1528
- CRB-1530
- CRB-1532
- CRB-1534
- CRB-1535
Distribution
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