Recall Z-1734-2024 ยท EOQ Bronchoscope (Flexible Or Rigid)
Noah Medical
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.
| Date | May 1, 2024 (initiated Mar 9, 2024) |
| Status | Open, Classified |
| Reason | Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope. |
| Root cause | Process control |
| Action | On 03/09-11/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx overnight to customers informing them that due to an misalignment calibration of wired controller, it potentially could cause unintended motion of the Galaxy bronchoscope. Customers are instructed to: -Not utilize any of the wired controllers -Remove from service -Return to Noah Medical For any questions, contact Customer Service at 888-325-6624, ext. 3 |
| Quantity | 17 wired controllers |
| Distribution | U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223144 | Galaxy System Noah Medical Corp., Mar 1, 2023 |