| Class 2 Device Recall Galaxy bronchoscope |  |
Date Initiated by Firm | October 25, 2024 |
Date Posted | December 13, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0679-2025 |
Recall Event ID |
95574 |
510(K)Number | K223144 |
Product Classification |
Bronchoscope (flexible or rigid) - Product Code EOQ
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Product | Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001) |
Code Information |
UDI-DI: 00850048825048. IFU Revision: J and all prior versions. All bronchoscope lots used with the following system 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, CRB1540, CRB-1541, CRB-1543, CRB1554 |
Recalling Firm/ Manufacturer |
Noah Medical 1501 Industrial Rd San Carlos CA 94070-4111
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Manufacturer Reason for Recall | Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated. |
FDA Determined Cause 2 | Device Design |
Action | On 10/25/24, recall notices were sent to customers who were asked to do the following:
A copy of this letter should be kept with the instructions for use which adds additional warnings and precautions to the section Working Channel Tools/Instruments on page 23 of the Instructions for Use.
CAUTION: If the bending section of the bronchoscope is articulated sharply and advancement of a biopsy tool encounters increased insertion resistance, straighten the bending section as much as possible to enable resumed advancement of the tool. Use of excessive force during instrument insertion may damage the instrument and/or the bronchoscope or result in tissue injury including pneumothorax. Certain instruments with longer rigid distal sections may exhibit increased insertion resistance when bronchoscope bending section is significantly articulated.
Firm has undertaken an investigation of which types of biopsy tools are most likely to result in binding and will make this information available as testing is completed. A replacement to the Instructions for Use with the Cautions herein and replacement instructions will be made available. Firm is also investigating technical solutions to make the working channel of the bronchoscope compatible with a wider range of biopsy tools and a wide degree of conformations in use.
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 | 26 |
Distribution | US Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC |
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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