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.
This recall has been terminated (originally issued April 3, 2012).
- Company
- Maquet Inc.
- Recall Initiated
- December 22, 2011
- Posted
- April 3, 2012
- Terminated
- October 22, 2013
- Recall Number
- Z-1363-2012
- Quantity
- 50 units US
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
USA Nationwide Distribution
Lot / Code Info
510k k041223 B052264 Article 66 40 440 Serial numbers 19841-21664
Root Cause
Device Design
Action Taken
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.