Fresenius Medical Care Holdings, Inc.: BPM3 Blood Pressure Modules Recalled for Failure to Record or Alarm

What You Should Do

1. Identify if your hemodialysis machine is affected by checking the model and part numbers. The BPM3 module (Model TM-2917B) is installed in 2008 Series Hemodialysis Machines with Part Numbers: 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130.
2. Verify the firmware version of the Blood Pressure Module; only units with firmware version S005 are included in this recall.
3. Check your machine's serial number against the list of over 1,500 affected units, including numbers such as 4T0S278166, 4T0S278222, 4T0S278232, 4T0S278242, and thousands of others listed in the recall documentation.
4. Healthcare facilities should immediately contact Fresenius Medical Care Holdings, Inc. to discuss the issue and obtain necessary technical guidance or firmware updates.
5. Patients and healthcare providers should contact their clinical team or the manufacturer directly if they have concerns about the reliability of blood pressure readings on these specific machines.
6. For more information or further instructions, contact Fresenius Medical Care at their Waltham, MA office or call the FDA's medical device recall line at 1-888-463-6332.

Your Remedy Options

Affected Products