Bronchoscopy robots recalled because the user manual was password protected
Noah Medical is recalling 47 Galaxy Systems because users did not have access to the Instructions for Use and User Manual, which was password protected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites inaccessible instructions rather than a device defect, and states no consequence or reported harm.
Plain-English summary
The Galaxy System, model GAL-001, from Noah Medical, is being recalled. The system and its accessories are intended to provide bronchoscopic visualisation of and access to patient airways.
The recall follows users not having access to the Instructions for Use and User Manual because it was password protected.
The recall covers 47 units carrying UDI 00850048825048, with serial numbers listed in the customer notification letter. The product was distributed in New York, Massachusetts, West Virginia, Wyoming, Tennessee, Ohio, New Jersey, Minnesota, California, Missouri, Idaho, Indiana, Pennsylvania, Maryland, Virginia, Wisconsin, Colorado and South Carolina. The FDA has classified the action as Class II.
The enforcement record describes an access problem with the documentation rather than a device defect, and reports no injuries. Sites should follow Noah Medical's instructions to obtain the manual.
The recalled product
- Product
- IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML
- Manufacturer
- B Braun Medical Inc
- Hazard
- inaccessible-instructions
- documentation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 1. Catalog Number: 490283
- Primary UDI-DI: 04046964716669
- Unit of Dose UDI-DI: 04046964716652.
Distribution
Distribution scope not specified by the agency.
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