Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden
This recall has been terminated (originally issued January 5, 2010).
- Company
- Maquet Inc.
- Recall Initiated
- November 17, 2009
- Posted
- January 5, 2010
- Terminated
- June 4, 2012
- Recall Number
- Z-0589-2010
- Quantity
- 29364 (8438 of those in US)
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.
Distribution
Worldwide distribution
Lot / Code Info
Serial Numbers 010001-188499 Ventilators within the specified serial number range, that are marked with one of the following labels on the inside of the lid of the pneumatic unit are exempted since they have already been fitted with a new type of the pressure transducer. 1. Upgrade EMO 12/02/1; 2. Upgrade SV300 6682-745 SV900 66 82 747.
Root Cause
Device Design
Action Taken
Maquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express.