Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warmin
FDA device recall Z-1463-2015 · posted 2015-04-20 · Terminated
Recall details
- Recalling firm
- Thermedx LLC
- Reason for recall
- To correct software bugs that could affect the ability to accurately measure fluid deficit.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HIG
- Quantity affected
- 127 units
- Distribution
- US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.
- Date initiated
- 2014-09-01
- Date posted
- 2015-04-20
- Date terminated
- 2015-09-14
- Location
- Solon, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THERMEDX FLUID MANAGMENT SYSTEM (K133799) | Thermedx, LLC | 2014-06-20 |
| THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 (K091939) | Thermedx, LLC | 2010-07-23 |