Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB,
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-0588-2010
- Quantity
- 20837 (7847 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 00410-24999. Ventilators in the specific range that are marked with one of the following labels are already equipped with the new type ot pressure transducer. 1. Upgrade EM008/02/1; 2. Upgrade SV300 66 82 745 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.
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