FDA Medical Device Recalls (openFDA)
MAQUET Inc.: Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside for intra-hospital transport.
- Recall number
- Z-1252-2009
- Recalling firm
- MAQUET Inc.
- Product
- Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside for intra-hospital transport.
- Status
- Terminated
- Initiated
- 2009-03-23
- Posted
- 2009-05-12
- Terminated
- 2009-11-16
- Reason
- The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails.
- Root cause
- Device Design
- Action
- An "Urgent: Device Correction" letter dated March 23, 2009 was sent by Federal Express to customers. The letter described the affected product, problem, indications, potential hazard and actions for users. Customers were instructed to complete the "Device Correction -- Customer Fax Response" form and return via fax (732-667-1903) to Maquet Inc. RA/QA. Direct questions to your local Maquet Inc. representative.
- Quantity
- 7,847 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- All units manufactured prior to June 2002.
- 510(k) numbers
- ["K902859","K970839"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3008355164
- Firm city
- Bridgewater
- 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