AutoPulse Resuscitation System Battery Recalled for Increased Li-ion Failures
ZOLL Circulation is recalling 6,353 AutoPulse Li-ion Batteries used in the AutoPulse Resuscitation System Model 100 CPR device due to an increase in battery failures. Affected users should contact the manufacturer for replacement guidance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a critical life-saving CPR adjunct where lithium-ion battery failures could impair device functionality. No reported illnesses, injuries, or deaths are documented in the source text, placing this at the 'High' level per the rubric for risk-of-harm products without reported harm.
Plain-English summary
ZOLL Circulation, Inc. is recalling 6,353 AutoPulse Li-ion Batteries used with the AutoPulse Resuscitation System Model 100. The AutoPulse system is a medical device designed to be used as an adjunct to manual cardiopulmonary resuscitation (CPR).
The recall was initiated due to an increase in Li-ion battery failures in certain units. The affected batteries are identified by specific serial numbers documented in the official recall notice.
The affected batteries were distributed throughout the United States (all 50 states, Puerto Rico, and the U.S. Virgin Islands) and internationally to numerous countries including Canada, Japan, Germany, United Kingdom, France, Australia, China, India, Mexico, and others.
Users who have AutoPulse systems with affected battery serial numbers should contact ZOLL Circulation, Inc. for information about replacement options and remediation procedures.
The recalled product
- Product
- AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
- lithium-ion-failure
Distribution
Distributed in 46 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- TX
- UT
- VA
- VT
- WA
- WI
- WV
- WY
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