FDA Medical Device Recalls (openFDA)
MAQUET Inc.: Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB
- Recall number
- Z-0588-2010
- Recalling firm
- MAQUET Inc.
- Product
- Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB,
- Status
- Terminated
- Initiated
- 2009-11-17
- Posted
- 2010-01-05
- Terminated
- 2012-06-04
- Reason
- 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.
- Root cause
- Device Design
- Action
- Maquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express.
- Quantity
- 20837 (7847 of those in US)
- Distribution
- Worldwide distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K902859","K970839"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28