CLASS III Device recall · Reported 12 Jun 2019 · FDA Enforcement Report

2008T BlueStar Machine recalled by Fresenius Medical Care Renal

Fresenius Medical Care Renal Therapies Group is recalling 2008T BlueStar Machine, distributed nationwide in the US. The recall was initiated on 3 Apr 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesSoftware v.2.72

Quantity recalled257 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1699-2019
FDA event ID: 82729
Recalling firm: Fresenius Medical Care Renal Therapies Group, Waltham, MA
Classification: Class III
Status: Terminated
Recall initiated: 3 Apr 2019
FDA classified: 31 May 2019
Reported: 12 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

3 Apr 2019	Recall initiated by company
31 May 2019	Classified by FDA	+58 days
12 Jun 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.

Which lots are affected?

Software v.2.72

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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