Outset Medical, Inc.: Tablo Hemodialysis Console Recalled for Faulty Blood Leak Sensor

What You Should Do

1. Identify if your device is affected by checking the serial number on the Tablo Console. Affected serial numbers include a large range such as 400405, 602382M, 602759M, 600948M, and over 2,400 others listed in the recall documentation.
2. Check for UDI-DI numbers 00850001011112 or 00850001011204 on the device labeling to confirm the model is part of this recall.
3. Healthcare providers and clinic administrators should immediately stop using units with the affected serial numbers if they show signs of sensor malfunction or as directed by the manufacturer's notification letter.
4. Contact Outset Medical, Inc. directly at their facility located at 3052 Orchard Dr, San Jose, California to receive technical guidance or to schedule a required sensor calibration/repair.
5. If you are a patient receiving treatment and notice any unusual symptoms like dizziness or shortness of breath during dialysis, alert your medical staff immediately.
6. For additional questions, contact the FDA medical device recall line at 1-888-463-6332 or visit the official FDA website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products