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This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

The FDA is aware that Draeger has issued a letter to affected customers recommending certain ErgoStar Catheter Mounts be removed from where they are used or sold:

What to Do

Do not use any unused affected product. Unused stock should be removed and returned to Draeger. FDA recommends replacing currently in use affected product with a comparable alternative when available and medically appropriate.

On November 10, Draeger sent all affected customers a letter recommending the following actions:

• Do not use any ErgoStar CM 40, CM 45, CM 55, or CM 60 stock.
• Remove unused stock and return to Draeger.
• Draeger recommends using the alternative product MP01850 ErgoStar CM 50 as a replacement. This is not an identical item, but a comparable alternative.
• Ensure all potential users in your facility are made aware of this Urgent Medical Device Recall Notice.
• If you have forwarded affected products to third parties, please also forward this Urgent Medical Device Recall Notice.

Reason for Alert

Draeger stated that they have become aware of cases in which cracks have formed in the hose of specific ErgoStar catheter mounts. If these cracks form during use, leakage will occur. Depending on the size of the leakage and the selected ventilation pressure, the ventilator/anesthesia device can compensate for this. If the leakage cannot be compensated for, ventilation is restricted and may lead to desaturation or hypoxia for the patient.

As of November 17, 2025, Draeger has not reported any serious injuries or deaths associated with this issue.

Device Use

The ErgoStar Airway Connector conducts respiratory gases between the breathing system and the patient interface (such as an endotracheal tube mask) of a mechanically ventilated patient.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Draeger Customer Service at US-Medical@draeger.com or 1-800-437-2437 (press 2 at the prompt, then 1).

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.  

Affected Products

What to Do

If the error message “Magnet Supervision: The average heater power is above the alarm threshold. Please contact Siemens Healthineers Service” appears on your host computer, no further scans can be performed. Follow additional safety actions immediately. 

On August 27, 2025, Siemens Healthineers sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:

• If the error message “Magnet Supervision: The average heater power is above the alarm threshold. Please contact Siemens Healthineers Service” appears on the host computer, take the following safety actions:
  • Do not reboot the system. 
  • Remove the patient from the system. 
  • Lock/secure all access to the scanning room with the system remaining energized at field. 
  • Post a “DO NOT USE” notice on or near the device.
  • Call the facility’s local Siemens Healthineers service organization.
  • Make sure all relevant personnel are aware of this issue.
• Be aware that the Magnet Stop is only intended for emergencies. DO NOT initiate a manual quench of the magnet unless there is an emergency.
• Ensure all designated emergency exit routes remain unobstructed at all times and are properly marked. In particular, the exit from the examination room must be maintained at all times.
• Grant access to the system so an inspection can be carried out as directed by Siemens Healthineers service organization. 
• Make sure all users of affected products and others who may need to be informed receive the relevant safety information provided within the notice and comply with its recommendations.
• If the equipment is no longer at the facility, forward the notice to the equipment’s new owner. 
• You may continue to use the system until an inspection has been performed.

Reason for Correction

Siemens Healthineers is correcting 3 Tesla Siemens Healthineers MRI systems due to the potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a sudden loss of superconductivity, or magnet quench, helium gas may be unable to escape through designated venting paths, leading to pressure build-up within the helium containment system. This pressure build up could rupture the helium containment system, potentially resulting in a massive helium leak into the scanning room. Rupture of the helium containment system may also manifest as an explosion, with overpressure in the MRI room and debris expelled forcefully.

The use of affected product may cause serious adverse health consequences, including cold burns, asphyxiation, trauma, and death.  

As of August 29, Siemens Healthineers has not reported any serious injuries or deaths related to this issue.

Device Use

Affected 3 Tesla Siemens Healthineers MRI systems include magnetic resonance diagnostic devices (MRDD) and mMR systems, which combine MRDD and Positron Emission Tomography (PET). These devices display the internal structure and/or function of the head, body, or extremities, and may be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.

Contact Information

Customers in the U.S. with questions about this recall should contact the Siemens Healthineers service organization at 1-800-888-7436.

Additional FDA Resources:  

• FDA’s Enforcement Report
• Medical Device Recall Database

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.  

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.