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Terminated

Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care

FDA Recall Z-0372-2007 · Posted 2007-01-25

Recalling FirmMAQUET Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2006-05-23
Date Terminated2008-04-11
Product Quantity1, 970 units

Reason for Recall

Reported failures of the SERVO-i ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is selected. Direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned.

Firm Action

Maquet sent an ''Extended Warranty'' letter on May 23, 2006. On March 13, 2007, Maquet issued a Recall Notification letter to all customers stating that they will replace all PC1777 boards in the serial number range 2400-3300, which have not previously been replaced. A safety alert letter was included outlining the failure indication and effect for the user of the failures, as well as, how to identify whether the Servo-i unit has shown any failure indications.

Root Cause

Other

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010925SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407ESiemens Elema AB · 2001-12-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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