Fluid Management System P4000 — Class II medical device recall Z-1463-2015
Terminated recall by Thermedx LLC, reported 2015-04-29, distributed in IL, LA, MA, MI, MS, NC, NY, OH…. To correct software bugs that could affect the ability to accurately measure fluid deficit.
| Recall number | Z-1463-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thermedx LLC, Solon, OH, United States |
| Recall initiated | 2014-09-01 |
| Classified | 2015-04-20 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2015-09-14 |
| Distributed | IL, LA, MA, MI, MS, NC, NY, OH, TX, WA, WV |
| Quantity | 127 units |
| Reason classes | software |
| Serial numbers | 20100001 |
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 for recall
To correct software bugs that could affect the ability to accurately measure fluid deficit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1463-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.