Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside for intra-hospital transport.
FDA Recall Z-1252-2009 · Posted 2009-05-12
Advertisement
Recalling FirmMAQUET Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2009-03-23
Date Terminated2009-11-16
Product Quantity7,847 units
Reason for Recall
The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails.
Firm Action
An "Urgent: Device Correction" letter dated March 23, 2009 was sent by Federal Express to customers. The letter described the affected product, problem, indications, potential hazard and actions for users. Customers were instructed to complete the "Device Correction -- Customer Fax Response" form and return via fax (732-667-1903) to Maquet Inc. RA/QA. Direct questions to your local Maquet Inc. representative.
Root Cause
Device Design
Distribution Pattern
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.
Advertisement