
Resuscitation System Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation System Due to Failure Code That May Stop Compressions or Deliver Inadequate CPR
ZOLL Circulation, Inc. is recalling the AutoPulse NXT Resuscitation System due to a failure code FC1060 that may cause the device to stop delivering chest compressions or fail to compress deeply enough, delaying life-saving CPR. ZOLL has advised users to stop using affected devices, wait for a loaner unit, and return the impacted system to ZOLL for repair and testing. If the fault occurs during use, CPR may be delayed or less effective, reducing blood flow to vital organs and increasing the risk of serious injury or death.
At this time, Zyno Medical has not reported any serious injuries or deaths related to this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact ZOLL Circulation, Inc. at 408-541-2140.
|