Recall Z-1568-2022— Getinge Usa Sales Inc
Class II · Ongoing
Class II FDA medical device recall by Getinge Usa Sales Inc, initiated 2022-07-21. It names one FDA 510(k) clearance: K192604. 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). Reason: Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk.
- Recalling firm
- Getinge Usa Sales Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-07-21
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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)
Reason for recall
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk
Data sourced from openFDA. This site is unofficial and independent of the FDA.