Recall Z-1925-2012 ยท BSZ Gas-Machine, Anesthesia
Maquet Cardiovascular Us Sales, Llc
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.
| Date | Jul 6, 2012 (initiated Feb 20, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | The firm, Maquet Getinge Group, sent an "URGENT DEVICE FIELD CORRECTION" letter dated February 20, 2012 to its customers. The letter describes the product, problem and action to be taken. The letter state that a Maquet Service Representative will upgrade the customers software in the FLOW-i Anesthesia System to the current revision and also provide the customers with the corresponding user's manual. Note: This upgrade includes other minor improvements. The customers were instructed to sign a document to verify satisfactory completion of the work once the software upgrade was completed. If yo |
| Quantity | 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 Afric |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112114 | MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 Maquet Critical Care AB, Jan 13, 2012 |