Recall Z-1533-2025— ZOLL Circulation, Inc.
Class I · Ongoing
Class I FDA medical device recall by ZOLL Circulation, Inc., initiated 2025-03-04. It names one FDA 510(k) clearance: K221700. Product: Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A. Reason: AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060..
- Recalling firm
- ZOLL Circulation, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-03-04
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A
Reason for recall
AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
Data sourced from openFDA. This site is unofficial and independent of the FDA.