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.
Recall
- Recall Number
- Z-1734-2024
- Event Number
- 94193
- Firm
- Noah Medical
- FEI Number
- 3021325287
- Product Code
- EOQ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- March 9, 2024
- Posted
- May 1, 2024
- Address
- 1501 Industrial Rd, San Carlos, CA, 94070-4111
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.
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
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
U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
17 wired controllers