FDA Device

Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, Sweden.

Hazard

Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.

What You Should Do

Remedy

Customer letter mailed on January 3, 2005 via certified postage, with return self-addressed postcards that customers must complete to acknowledge receipt of the instructions to refer to their Service and Operating Manuals.

Products

Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, S
Brand
Maquet Inc
UPC
All units with the Serial Numbers 24578 and lower. Total of 7920 units.

Units Affected

7920 units