| Class 2 Device Recall |  |
Date Initiated by Firm | October 28, 2024 |
Date Posted | December 20, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0742-2025 |
Recall Event ID |
95585 |
510(K)Number | K223144 |
Product Classification |
Bronchoscope (flexible or rigid) - Product Code EOQ
|
Product | Galaxy System (GAL-001).
Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. |
Code Information |
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, |
Recalling Firm/ Manufacturer |
Noah Medical 1501 Industrial Rd San Carlos CA 94070-4111
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Manufacturer Reason for Recall | Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax. |
FDA Determined Cause 2 | Component change control |
Action | On 10/28/24, recall notices were sent to customers who were told the firm would contact them to arrange inspection and replacement of the power supply system.
Share this notification with any other healthcare professionals who may use the system.
Complete and return the response form.
Firm customer Service: customerservice@noahmed.com, 888-325-6624 |
Quantity in Commerce | 18 |
Distribution | US: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = EOQ
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