Draeger Infinity Acute Care System Monitoring Solution recall
Draeger Infinity Acute Care System Monitoring Solution
Why was Draeger Infinity Acute Care System Monitoring Solution recalled?
After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.
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?
with software versions VG2.0.3 and higher.
- Product
- Draeger Infinity Acute Care System Monitoring Solution
- Recalling firm
- Draeger Medical Systems, Inc.
- Quantity
- 439
- Distribution
- US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
- Recall date
- January 22, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)