Reported Dec 25, 2024 · Ongoing
Galaxy System (GAL-001)
Noah Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Noah Medical · 1501 Industrial Rd · San Carlos, CA · 94070-4111
Is this the product you have?
- Galaxy System (GAL-001)
- Lot codes and dates
- UDI-DI00850048825048
- Serial Numbers
CRB-1502CRB-1503CRB-1508CRB-1513CRB-1514CRB-1515CRB-1516CRB-1518CRB-1519CRB-1520CRB-1521CRB-1522CRB-1523CRB-1524CRB-1525CRB-1528CRB-1530CRB-1532CRB-1534CRB-1535CRB-1537CRB-1538CRB-1540CRB-1541CRB-1543CRB-1554
- Amount recalled
- 26
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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