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10 Biggest Medical Device Recalls of 2016—Dexcom

DexcomDevice:Reason for the recall:When:Number of U.S. units impacted:For more information, visit the FDA Recall page.

Dexcom

Device: The Dexcom G4 PLATINUM REceiver, G4 PLATINUM (Pediatric) Receiver, G4 PLATINUM (Professional) Receiver, G4 PLATINUM Receiver with Share, G4 PLATINUM (Pediatric) Receiver with Share, G5 Mobile Receiver

Recall reason: According to information on the FDA recall page, "the audible alarm may not activate in the receiver piece when low or high glucose levels . . . are detected. Relying on this product for notification of low or high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low or high blood sugar."

When recall was initiated: February 23, 2016

Number of U.S. units impacted: 263,520 units

For more information, visit the FDA Recall page.

             

[Image courtesy of FDA RECALL PAGE]

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