Recall Z-1463-2015
Thermedx LLC · initiated September 1, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Serial Numbers 20100001 through 20140044
Reason for recall
To correct software bugs that could affect the ability to accurately measure fluid deficit.
FDA-determined cause: Software design
Action taken
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 available toll free at 1-888-542-9276 from 8AM to 5PM Monday to Friday Eastern Standard Time or by e-mailing techservice@thermedx.com. Our website may be found at www.thermedx.com. We sincerely apologize for the inconvenience and thank you in advance for your cooperation.
Details
- Recall number
- Z-1463-2015
- Initiated
- September 1, 2014
- Posted by FDA
- April 20, 2015
- Terminated
- September 14, 2015
- Product code
- HIG – Insufflator, Hysteroscopic
- Quantity
- 127 units
- Distribution
- US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.
- Recalling firm
- Thermedx LLC, Solon, OH