Maquet Servo-i ventilator system Device Part number 64 87 800 Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport.
FDA Recall Z-0352-2012 · Posted 2011-12-02
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Recalling FirmMaquet Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2011-09-19
Date Terminated2015-07-22
Product Quantity166 units
Reason for Recall
Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24).
Firm Action
The firm, Maquet Getinge Group, sent an " PRODUCT RECALL URGENT - MEDICAL DEVICE CORRECTIVE ACTION" letter dated September 19, 2011, to its customers. The letter describes the product, problem and actions to be taken. Maquet service team will contact the customers within two weeks of receiving this letter to schedule an on-site service of the affected equipment.
If you have any questions, call technical support at our toll free number at 1-888-627-8383.
Root Cause
Vendor change control
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.
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