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.
Reported: July 18, 2012 Initiated: February 20, 2012 #Z-1925-2012
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.
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.
Details
- Recalling Firm
- Maquet Cardiovascular Us Sales, Llc
- Units Affected
- 284 units
- Distribution
- 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.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 284 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 18, 2012. Severity: Critical. Recall number: Z-1925-2012.
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