Recall Z-1824-2014 ยท DQA Oximeter
Spacelabs Healthcare Inc
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
| Date | Jun 18, 2014 (initiated May 9, 2014) |
| Status | Terminated |
| Reason | Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor. |
| Root cause | Component change control |
| Action | Spacelabs changed their strategy for updating the software and sent the updated letter Urgent-Medical Device Correction- Hamilton Galileo Ventilator Flexport Model 90436A-07, dated 10 June 2015, to their consignees. The firm is going to send consignees new replacement flexport(s) with upgraded software and requested consignees to return old affected units via Return Goods Authorization (RGA) to Spacelabs and the firm will destroy affected units. Consignees are instructed to take the following actions: 1. Please replace the affected devices and test for correct operation. 2. Return your ol |
| Quantity | 46 units distributed within the US; 108 units distributed outside the US. |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903702 | MODEL 90421 FLEXPORT INTERFACE Spacelabs, Inc., Oct 19, 1990 |