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U.S. Department of Health and Human Services

Class 2 Device Recall eVent Medical Ltd

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 Class 2 Device Recall eVent Medical Ltdsee related information
Date Initiated by FirmAugust 12, 2005
Date PostedOctober 15, 2005
Recall Status1 Terminated 3 on February 29, 2012
Recall NumberZ-0062-06
Recall Event ID 33276
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
ProductINSPIRATION 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
Code Information All serial numbers for Models F7100000-XX, F7200000-XX, and F7300000-XX
FEI Number 3006135941
Recalling Firm/
Manufacturer		 Event Medical
2440 Grand Ave
Vista CA 92081-7829
Manufacturer Reason
for Recall		Firm received reports of combustion within the blender system of the Inspiration Ventilator.
FDA Determined
Cause 2		Other
ActionCustomer 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.
Quantity in Commerce1,602 units
DistributionNationwide and Canada, Europe, Japan, Latin America, Asia/Pacific, Middle East
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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