Recall Z-1533-2025 ยท DRM Compressor, Cardiac, External
ZOLL Circulation, Inc.
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
| Date | Apr 11, 2025 (initiated Mar 4, 2025) |
| Status | Open, Classified |
| Reason | AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060. |
| Root cause | Process change control |
| Action | On March 4, 2025, Zoll Circulation issued a "Medical Device Product Correction Notice" to affected consignees. Zoll asked consignees to take the following actions: 1. Stop using your affected platform(s) immediately. Your patients may not receive high-quality compressions. 2.Complete the Customer Acknowledgment/ No-Charge AP NXT Platform Repair Request Form (page 3)and email it to dlam@zoll.com within 3 days. Please feel free to call me at (408) 419 - 2955 if you have any questions. 3.Return your affected platform(s) to ZOLL as soon as you receive the loaner AP NXT Platform(s) from ZOLL. |
| Quantity | 91 |
| Distribution | US: AL, CA, CT, FL, IL, KS, LA, MN, MO, MT, NC, ND, NM, NY, OH, OK< PA, TX, WI OUS: Canada, Hong Kong, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221700 | AutoPulse NXT Resuscitation System Zoll Circulation, Inc., Mar 9, 2023 |