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.
FDA Recall Z-1463-2015 · Posted 2015-04-20
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Recalling FirmThermedx LLC
Recall StatusTerminated
Product CodeHIG
Date Initiated2014-09-01
Date Terminated2015-09-14
Product Quantity127 units
Reason for Recall
To correct software bugs that could affect the ability to accurately measure fluid deficit.
Firm 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 available toll free at 1-888-542-9276 from 8AM to 5PM Monday to Friday Eastern Standard Time or by e-mailing [email protected]. Our website may be found at www.thermedx.com. We sincerely apologize for the inconvenience and thank you in advance for your cooperation.
Root Cause
Software design
Distribution Pattern
US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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