Z-1463-2015 Class II Terminated
FDA device recall Z-1463-2015 was initiated by Thermedx LLC on September 1, 2014 and is designated Class II. Reason for recall: To correct software bugs that could affect the ability to accurately measure fluid deficit. The recall status is terminated (terminated September 14, 2015). Affected quantity: 127 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2015
- Initiation Date
- September 1, 2014
- Termination Date
- September 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 127 units
Product Description
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.
Reason for Recall
To correct software bugs that could affect the ability to accurately measure fluid deficit.
Distribution Pattern
US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.
Code Information
Serial Numbers 20100001 through 20140044