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Terminated

INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language variant. IN = English (International); GB=English (US); FR= French; DE=German; IT=Italian; PT=Portuguese; ES=Spanish; JP=Japanese; PL=Polish; RU=Russian

FDA Recall Z-0062-06 · Posted 2005-10-15

Recalling FirmEvent Medical
Recall StatusTerminated
Product CodeCBK
Date Initiated2005-08-12
Date Terminated2012-02-29
Product Quantity1,602 units

Reason for Recall

Firm received reports of combustion within the blender system of the Inspiration Ventilator.

Firm Action

Customer shall be notified by an Urgent Product Safety Notfication letter dated August 12, 2005. The letter shall advise the customer with the specifics of this problem, summarise the fact that the hazard potential in negligible and will advise the customer regarding options for replacement of the Blender Module assembly (part number F710400) and the Air/O2 Filters (part number F910300). The letter will also provide the customers with a set of actions which can be completed immediately in order to ensure the integrity of their gas supplies until their unit has been upgraded.

Root Cause

Other

Distribution Pattern

Nationwide and Canada, Europe, Japan, Latin America, Asia/Pacific, Middle East

Official Source

View FDA Recall →

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

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