FDA Medical Device Recalls (openFDA)
MAQUET Inc.: SERVO-s Ventilator System, Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
- Recall number
- Z-2443-2008
- Recalling firm
- MAQUET Inc.
- Product
- SERVO-s Ventilator System, Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
- Status
- Terminated
- Initiated
- 2008-07-08
- Posted
- 2008-09-23
- Terminated
- 2008-12-23
- Reason
- Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators.
- Root cause
- Employee error
- Action
- Urgent - Device Correction notices were sent out to all customers on July 7, 2008. The letter informed the customers of the affected product, and associated hazards. The letter instructed customers to take an inventory of the product and it provided actions to be taken until affected products are replaced. Contact Maquet at 1-888-627-8383#1, for assistance.
- Quantity
- 122 total (SERVO-i and SERVO-s) in US.
- Distribution
- Worldwide.
- Lot, serial or model codes
- Article Number: 66-40-440 Serial numbers: 7591, 7604, 7605, 7606, 7607, 7608, 7609, 7610, 7613 through 7666, 7676, 7677, 7678, 7879, 7680, 7681, 7682, 7686 through 7703, 7709 through 7724, 7737, 7740, 7745, 7749, 7750, 7758, 7759, 7760, 7763, 7764, 7770, 7771, 7772, 7775, 7776, 7777, 7778, 7779, 7800 through 7825
- 510(k) numbers
- ["K041223"]
- 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