Recall Z-0062-06 ยท CBK Ventilator, Continuous, Facility Use
Event Medical
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
| Date | Oct 15, 2005 (initiated Aug 12, 2005) |
| Status | Terminated |
| Reason | Firm received reports of combustion within the blender system of the Inspiration Ventilator. |
| 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 | 1,602 units |
| Distribution | Nationwide and Canada, Europe, Japan, Latin America, Asia/Pacific, Middle East |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.