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NX2ME APP
NXSTAGE MEDICAL, INC. · Model NX3094 · UDI-DI 00842289101883
FKP
Prescription
10
510(k) clearances
1,072
Adverse events (93 deaths)
12
Recalls
3
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-01-29 | Baxter Healthcare Renal Div | Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software. |
| 2009-11-20 | Fresenius Medical Care North America | Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy. |
| 2009-11-20 | Fresenius Medical Care North America | Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy. |
| 2008-05-23 | Hach Co | Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results |
| 2008-05-23 | Hach Co | Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results |
| 2008-05-23 | Hach Co | Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results |
| 2008-05-23 | Hach Co | Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results |
| 2006-02-24 | Baxter Healthcare Renal Div | The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical and thermal stress. If eithe |
| 2003-05-28 | Baxter Healthcare Renal Div | The air detector may not detect air bubbles consistently at the selected limit. |
| 2003-03-20 | Baxter Healthcare Corp. | The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.