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NxStage System One-Cycler (Chronic Application) (2015-10-30)
- Starting date:
- October 30, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55866
Affected Products
NxStage System One-Cycler (Chronic Application)
Reason
NxStage has identified a software error in the NxStage System One S Cycler Model No. Nx1000-3 with software versions 4.9 and 4.10. If specific conditions are met and a software error does occur, the ultrafiltration (UF) volume target will not decrease during the treatment even if the uf pump is running.
Affected products
NxStage System One-Cycler (Chronic Application)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not Applicable
Companies
- Manufacturer
-
NxStage Medical, Inc.
350 Merrimack Street
Lawrence
01843
Massachusetts
UNITED STATES