2008T, Hemodialysis Delivery System Product Indicated recall: Software Issue
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Why was 2008T, Hemodialysis Delivery System Product Indicated recalled?
While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
2008T machines: 190766 2008T Hemodialysis System w/Bibag 190895 2008T GEN 2 Bibag without CDX 190766 = 00840861100910 (+Serial Number) 190895 = 00840861100927 (+Serial Number)ux=&Su
- Product
- 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Quantity
- 15 machines
- Distribution
- US Nationwide Distribution
- Recall date
- March 7, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)