Servo-air Ventilator Systems Lack Required Stability Warning Markings
Getinge is recalling Servo-air Ventilator Systems because they lack required warning markings about stability risks when stationary. A total of 102 units were distributed in the US; 13,750 units were distributed internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for respiratory support equipment with missing required safety warning markings about stability risks. No injuries or deaths have been reported. The situation meets the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Getinge Usa Sales Inc is recalling Servo-air Ventilator System models 6882000 equipped with mobile cart 6881999. These medical devices provide respiratory support, monitoring, and treatment for pediatric and adult patients. The recall affects 102 units distributed in the US and 13,750 units distributed internationally to countries including Australia, Brazil, China, Japan, Mexico, and others.
The devices do not meet FDA regulatory requirements regarding stability while stationary. Federal regulations require that mechanical equipment intended for floor or table use must be permanently marked with a clear warning about stability risks. The recalled units lack this required warning marking.
Healthcare facilities using the affected serial numbers should verify their equipment against the recall list provided in the FDA notice. The device UDI-DI is 07325710003114. A complete list of affected serial numbers is available in the recall documentation.
The recalled product
- Product
- Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
- Manufacturer
- Getinge Usa Sales Inc
Distribution
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