Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended
Summary
The FDA issued a Class II for Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy by Noah Medical. Reason: Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope..
Details
Source
Device Recall
External ID
Z-1734-2024
Action Date
2024-05-08
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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
Quantity Affected: 17 wired controllers
Reason for Recall
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Distribution
U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-09
Company
San Carlos, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 175 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Noah Medical has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Noah Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Noah Medical have FDA actions?
Noah Medical has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1734-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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