CLASS II ONGOING Device recall · Reported 25 Dec 2024 · FDA Enforcement Report
Galaxy System (GAL-001) recalled by Noah Medical
Noah Medical is recalling Galaxy System (GAL-001), distributed in 16 states. The recall was initiated on 25 Oct 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-0693-2025
- FDA event ID
- 95712
- Recalling firm
- Noah Medical, San Carlos, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Oct 2024
- FDA classified
- 18 Dec 2024
- Reported
- 25 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 25 Oct 2024 | Recall initiated by company | |
| 18 Dec 2024 | Classified by FDA | +54 days |
| 25 Dec 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
Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Galaxy System (GAL-001)
Where it was distributed
US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY
CaliforniaConnecticutIdahoIllinoisIndianaMassachusettsMarylandMissouriNorth CarolinaNew JerseyNew YorkOhioPennsylvaniaTennesseeVirginiaWest Virginia
Questions about this recall
Why was it recalled?
Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.
Which lots are affected?
UDI-DI: 00850048825048. 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, CRB-1540, CRB-1541, CRB-1543, CRB-1554
Where was it sold?
US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY
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 bronchoscope (Product Galb-001) used recalled by Noah Medical | Noah Medical | Other | Nationwide |
| Device | CLASS II | Galaxy System recalled by Noah Medical | Noah Medical | Other | Nationwide |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |