FDA issues emergency recall on resuscitation systems due to failure code
The U.S. Food and Drug Administration (FDA) has issued a Class I recall—the most serious type—on a commonly used resuscitation aid due to a defect that could result in CPR not being properly administered.
The AutoPulse NXT Resuscitation System, manufactured by Zoll, is a portable, battery-operated device designed to assist with CPR, particularly for patients who are unconscious and not breathing on their own.
It administers chest compressions as appropriate, under the supervision of emergency care technicians. However, a failure code—FC1060—is being displayed on certain models of the device, signaling that chest compression depth is inadequate. This could lead to reduced blood flow to vital organs, potentially resulting in death.
There have been no reported injuries. However, due to the serious potential complications linked to this malfunction, the FDA is recalling the devices from wherever they are in use, and technicians and clinicians are instructed to find immediate alternatives.
What is being recalled?
Only one model of the AutoPulse NXT Platform is subject to the recall—model 200. Details are as follows:
- Catalog Number: 8700-001070-1
- Software Version: Version 2.0.1
The FDA recall notice includes a list of all known Unique Device Identifiers (UDIs) and serial numbers associated with the recalled systems. These can be found here.
Next Steps
Customers should have received an Urgent Medical Device Recall Notice on March 4 from Zoll, which will contain the same information as the FDA alert.
The company is instructing all users to immediately discontinue deployment of the recalled Model 200 AutoPulse NXT resuscitation devices. Affected systems are to be returned for a loaner, while Zoll makes repairs to a pulley assembly blamed for the failure code.
After proper testing, repaired systems will be returned to users. Until a loaner can be acquired, all clinicians and emergency technicians will need to find replacement or backup resuscitation devices to use.
For more information, Zoll can be contacted at 408-541-2140.
The full recall notice from the FDA can be once again found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.