Ge Healthcare, Llc: TruSat Pulse Oximeter Recalled for Electrical Current Leak and Burn Risk

Agency Publication Date: May 19, 2010

Summary

Approximately 20 units of the Datex-Ohmeda TruSat Pulse Oximeter (Model 3500) and its accessories are being recalled because the external power supply may leak electrical current. This defect does not comply with current safety standards and can cause serious harm, including third-degree burns or life-threatening heart rhythm issues. These veterinary medical devices were distributed in CA, TX, NC, LA, CT, OR, MT, and UT starting in April 2010.

Risk

The external power supply can leak electrical current into the device and the patient. This electrical exposure can lead to third-degree burns at the site of contact or cause an abnormal heart rhythm that may result in death if not treated immediately.

What You Should Do

Identify your device by checking the label for 'Datex-Ohmeda TruSat Pulse Oximeter and Accessories, Model 3500' and Recall Number V-186-2010.
Check the external power supply connected to your TruSat device to see if it matches the affected model series.
Contact GE Healthcare at their Waukesha, Wisconsin headquarters or your local GE Healthcare representative to verify if your specific unit is among the 20 affected devices.
If your device is affected, contact your healthcare provider or GE Healthcare immediately for further instructions and information regarding potential repairs or a refund.
For additional questions or to report an issue, contact the FDA's consumer hotline at 1-888-INFO-FDA (1-888-463-6332).

Your Remedy Options

Other Action

Manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500

Model:

MODEL 3500

V-186-2010

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 55501

Status: Resolved

Manufacturer: Ge Healthcare, Llc

Sold By: GE Healthcare authorized distributors

Manufactured In: United States

Units Affected: 20

Distributed To: California, Texas, North Carolina, Louisiana, Connecticut, Oregon, Montana, Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

Summary

What You Should Do

Identify your device by checking the label for 'Datex-Ohmeda TruSat Pulse Oximeter and Accessories, Model 3500' and Recall Number V-186-2010.

Check the external power supply connected to your TruSat device to see if it matches the affected model series.

Contact GE Healthcare at their Waukesha, Wisconsin headquarters or your local GE Healthcare representative to verify if your specific unit is among the 20 affected devices.

If your device is affected, contact your healthcare provider or GE Healthcare immediately for further instructions and information regarding potential repairs or a refund.

For additional questions or to report an issue, contact the FDA's consumer hotline at 1-888-INFO-FDA (1-888-463-6332).