Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Cat
FDA device recall Z-1533-2025 · posted 2025-04-11 · Open, Classified
Recall details
- Recalling firm
- ZOLL Circulation, Inc.
- Reason for recall
- AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- DRM
- Quantity affected
- 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,
- Date initiated
- 2025-03-04
- Date posted
- 2025-04-11
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AutoPulse NXT Resuscitation System (K221700) | Zoll Circulation, Inc. | 2023-03-09 |