FDA Medical Device Recalls (openFDA)
MAQUET Inc.: Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden
- Recall number
- Z-0589-2010
- Recalling firm
- MAQUET Inc.
- Product
- Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden
- 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
- 29364 (8438 of those in US)
- Distribution
- Worldwide distribution
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K871254","K884520"]
- 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