Merge Healthcare recall
Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo…
Why was Merge Healthcare recalled?
It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the pulse rate of the SpO2 finger clip to calculate the patient's heart rate, it too may be subject to displaying a stale value.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Merge Hemo 9.x with Nellcor SpO2
- Product
- Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo…
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 52
- Distribution
- Nationwide Distribution including the states of AZ, CA, FL, IL, IA, MA, MO, OH, SC, TN, and WI.
- Recall date
- November 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)