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Terminated

Servo-i Ventilator

FDA Recall Z-0878-05 · Posted 2005-06-08

Recalling FirmMaquet Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2005-03-24
Date Terminated2005-09-08
Product Quantity4379 units

Reason for Recall

Complaints about batteries indicating a satisfying remaining time but after a short time suddenly shut off without giving alarms to indicate short remaining battery back-up time. (Power off alarm will be given).

Firm Action

Maquet sent out a Safety alert Letter on 3/31/2005 to all users of the Servo-i.

Root Cause

Other

Distribution Pattern

The ventilators were distributed nationwide to hosptials and clinics.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040221SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407EMaquet Critical Care AB · 2004-02-20

Official Source

View FDA Recall →

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

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