Z-0062-06

INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language...

Name: Z-0062-06 INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language...
Creator: Event Medical
Published: 2005-08-12
License: https://open.fda.gov/license/

Event Medical Ltd / initiated 2005-08-12 / Terminated

FDA source

Event Medical began a recall of INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language variant. IN = English (International); GB=English... on 2005-08-12. The reason FDA records is "Firm received reports of combustion within the blender system of the Inspiration Ventilator". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0062-06
Status: Terminated
Initiated: 2005-08-12
Posted: 2005-10-15
Terminated: 2012-02-29
Recalling firm: Event Medical Ltd
Product: 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
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Firm received reports of combustion within the blender system of the Inspiration Ventilator.
FDA root cause: Other
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.
Quantity in commerce: 1,602 units
Distribution: Nationwide and Canada, Europe, Japan, Latin America, Asia/Pacific, Middle East
Product codes and lots: All serial numbers for Models F7100000-XX, F7200000-XX, and F7300000-XX

Product code CBK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)