CLASS II ONGOING Device recall · Reported 8 May 2024 · FDA Enforcement Report
Galaxy System recalled by Noah Medical
Noah Medical is recalling Galaxy System, distributed nationwide in the US. The recall was initiated on 9 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1734-2024
- FDA event ID
- 94193
- Recalling firm
- Noah Medical, San Carlos, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Mar 2024
- FDA classified
- 1 May 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Mar 2024 | Recall initiated by company | |
| 1 May 2024 | Classified by FDA | +53 days |
| 8 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
Nationwide CaliforniaIndianaMarylandMissouriOhioPennsylvania
Questions about this recall
Why was it recalled?
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Which lots are affected?
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
Where was it sold?
U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Noah Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Galaxy System recalled by Noah Medical | Noah Medical | Other | 20 states |
| Device | CLASS II | Galaxy System (GAL-001) recalled by Noah Medical | Noah Medical | Device Malfunction | 15 states |
| Device | CLASS II | Galaxy System (GAL-001) recalled by Noah Medical | Noah Medical | Device Malfunction | 16 states |
| Device | CLASS II | Galaxy bronchoscope (Product Galb-001) used recalled by Noah Medical | Noah Medical | Other | Nationwide |
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