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)
Reported: August 31, 2022 Initiated: July 21, 2022 #Z-1568-2022
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
Details
- Recalling Firm
- Getinge Usa Sales Inc
- Units Affected
- US 102 units; OUS 13750 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia (AU), Brazil (BR), China (CN), Egypt (EG), EEA, Hong Kong (HK), Israel (IL), Japan (JP), Mexico (MX), Pakistan (PK), Saudi Arabia (SA), South Africa (ZA), South Korea (KR), Switzerland (CH), Taiwan (TW), Turkey (TR), and United Arab Emirates (AE).
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Getinge Usa Sales Inc. Units affected: US 102 units; OUS 13750 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2022. Severity: Moderate. Recall number: Z-1568-2022.
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