FDA Device recall Z-1463-2015
Fluid Management System P4000
- FDA Device
- Class II
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class II recall of Fluid Management System P4000 by Thermedx, citing to correct software bugs that could affect the ability to accurately measure fluid deficit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1463-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-01 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Thermedx |
| Distribution | IL, LA, MA, MI, MS, NC, NY, OH, TX, WA, WV |
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.
Reason
To correct software bugs that could affect the ability to accurately measure fluid deficit.
Identifiers
| code_info | Serial Numbers 20100001 through 20140044 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1463-2015%22
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