Recall Z-1463-2015 ยท HIG Insufflator, Hysteroscopic
Thermedx LLC
Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.
| Date | Apr 20, 2015 (initiated Sep 1, 2014) |
| Status | Terminated |
| Reason | To correct software bugs that could affect the ability to accurately measure fluid deficit. |
| Root cause | Software design |
| Action | Thermedx sent an Urgent Product Correction letter dated March 13. 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm informed their customers that the software update will be performed at customer locations by Thermedx trained and authorized personnel. A Thermedx and/or your Sales Representative will contact customers to schedule a time to perform the field service update. Should you have any questions regarding this notification, please call a Thermedx technical service representative. Support is availa |
| Quantity | 127 units |
| Distribution | US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL. |
| FDA record | Open on fda.gov |