SERVO-i 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.
FDA Recall Z-2442-2008 · Posted 2008-09-23
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Recalling FirmMAQUET Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2008-07-08
Date Terminated2008-12-23
Product Quantity122 units (SERVO-i and SERVO-s) units in United States
Reason for Recall
Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Worldwide.
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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