2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 008408
FDA device recall Z-1278-2018 · posted 2018-03-20 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Reason for recall
- When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.
- Action taken
- The recall notification instructs the user to the UF Goal with values less than 200ml when in Service Mode and to monitor and set the UF Rate to the desired setting after starting the SLED treatment. The consignee is advised that a software update is forthcoming to correct the issue. For further questions, please call (800) 227-2572.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 127
- Distribution
- US Distribution to the states of: AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX.
- Date initiated
- 2017-12-14
- Date posted
- 2018-03-20
- Date terminated
- 2021-09-22
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 2008K2 Hemodialysis Machine (K153449) | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-26 |