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U.S. Department of Health and Human Services

Class 2 Device Recall Galaxy System

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  Class 2 Device Recall Galaxy System see related information
Date Initiated by Firm March 09, 2024
Date Posted May 01, 2024
Recall Status1 Open3, Classified
Recall Number Z-1734-2024
Recall Event ID 94193
510(K)Number K223144  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
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.
Code Information Model Number: GAL-001 Wired Controller Model Number: GAL-019 UDI-DI code: 00850048825048 (additional information pending) Serial Numbers: 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 GWC-1537
Recalling Firm/
Manufacturer		 Noah Medical
1501 Industrial Rd
San Carlos CA 94070-4111
For Additional Information Contact Jian Zhang, Ph.D.
560-861-0191
Manufacturer Reason
for Recall		 Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
FDA Determined
Cause 2		 Process control
Action On 03/09-11/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx overnight to customers informing them that due to an misalignment calibration of wired controller, it potentially could cause unintended motion of the Galaxy bronchoscope. Customers are instructed to: -Not utilize any of the wired controllers -Remove from service -Return to Noah Medical For any questions, contact Customer Service at 888-325-6624, ext. 3
Quantity in Commerce 17 wired controllers
Distribution U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = EOQ and Original Applicant = Noah Medical Corp.
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