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Galaxy bronchoscope (Product GALB-001) used with… recallZ-0679-2025 · Noah Medical · initiated Oct 25, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Noah Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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: [email protected], 888-325-6624

Recall details

Recall number
Z-0679-2025
Status
Open, Classified
Initiated by the company
Oct 25, 2024
Posted by the FDA
Dec 13, 2024
Recalling firm
Noah Medical
Quantity
26
Product code
EOQ
FDA submissions
K223144
Distribution
US Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC

Product description

Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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