Reported May 8, 2024 · Ongoing
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended…
Noah Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Noah Medical · 1501 Industrial Rd · San Carlos, CA · 94070-4111
Is this the product you have?
- 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 codes and dates
- Model NumberGAL-001
- Wired Controller Model NumberGAL-019
- UDI-DI code00850048825048 (additional
- information pending) Serial Numbers
GWC-1529GWC-1538GWC-1541GWC-1576GWC-1579GWC-1560GWC-1566GWC-1586GWC-1590GWC-1581GWC-1589GWC-1552GWC-1572GWC-1547GWC-1571GWC-1564GWC-1537
- Amount recalled
- 17 wired controllers
Where it was sold
Why it was recalled
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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