Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported June 12, 2019
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Fresenius Medical Care Renal Therapies Group, LLC recalled 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Prod… - a low-severity action.
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Prod… was recalled by Fresenius Medical Care Renal Therapies Group, LLC in June 12, 2019. Reason: Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.. Check the official notice for the remedy. Verify recall #Z-1699-2019 with the FDA Devices before acting.
The recall
Fresenius Medical Care Renal Therapies Group, LLC issued this low-severity FDA Devices recall-Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72..
- Low
- severity level
- 257 units
- affected scope
- Class III
- classification
- June 12, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1699-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1699-2019) was formally reported on June 12, 2019, with the manufacturer initiating the action on April 3, 2019. It is classified under Low severity (Class III), with a current status of Terminated. Fresenius Medical Care Renal Therapies Group, LLC is listed as the recalling firm, operating out of Waltham, MA. Federal records list the affected scope as 257 units.
The documented reason for this recall is: Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72. Distribution data in the federal record shows the product reached: US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
257 units
Related Recalls
6
3 from same agency
Product description
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
Reason for recall
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1699-2019 |
| Date reported | June 12, 2019 |
| Date initiated | April 3, 2019 |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC |
| Firm location | Waltham, MA |
| Affected scope | 257 units |
| Distribution | US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1699-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.. Recalled by Fresenius Medical Care Renal Therapies Group, LLC. Units affected: 257 units.
Why was this product recalled? ▼
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2019. Severity: Low. Recall number: Z-1699-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1699-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 12, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.