Enforcement Report - Week of July 18, 2012
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Product Detail
| Product Description | FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. |
|---|---|
| Recall Number | Z-1925-2012 |
| Classification | Class I |
| Code Info | Model Number :6677300 Serial Number : 1170 |
| Product Distributed Qty | 284 units |
| Reason For Recall | A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "off" position but remains in the "in-between position. |
Event Detail
| Event Id | 62118 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Maquet Cardiovascular Us Sales, Llc |
| City | Wayne |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-02-20 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (nationwide) state of GA only and countries of: Argentina, Australia, Austria, Belgium, China, Czech Republic, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, Spain, Sweden incl Maquet Critical Care, Switzerland, Thailand, United Arab Emirates, and United Kingdom. |
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