FDA-Device2022-09-28Class II
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Covidien Llc
Hazard
Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.
Sold states
Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.
Affected count
5 US
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1775-2022Don't want to check this manually?
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