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.
FDA Recall Z-1363-2012 · Posted 2012-04-03
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Recalling FirmMaquet Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2011-12-22
Date Terminated2013-10-22
Product Quantity50 units US
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
USA Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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