FDA Medical Device Recalls (openFDA)
Maquet Inc.: Servo-s ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
- Recall number
- Z-1363-2012
- Recalling firm
- Maquet Inc.
- Product
- Servo-s ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
- Status
- Terminated
- Initiated
- 2011-12-22
- Posted
- 2012-04-03
- Terminated
- 2013-10-22
- Reason
- The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing.
- Root cause
- Device Design
- Action
- Maquet sent a Product Recall Urgent-Medical Device Corrective Action letter dated December 22, 2011 to all affected customers. The letter identified the affected products, patient risk, product issue and actions to be taken. Customers were instructed to complete and return the attached Customer Fax Response form as soon as possible. Maquet Field Service Technicians will update all affected products at all the concerned customer sites. Customers are advised untill Maquet has updated all the affected products (all of which are still under warranty), inform all the concerned biomedical staff about the content of this Device Correction Letter. For technical support call 1-888-627-8383.
- Quantity
- 50 units US
- Distribution
- USA Nationwide Distribution
- Lot, serial or model codes
- 510k k041223 B052264 Article 66 40 440 Serial numbers 19841-21664
- 510(k) numbers
- ["K041223"]
- 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