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AutoPulse®Resuscitation System
Zoll Circulation, Inc. · Model 100 · UDI-DI 00849111001007
DRM
Prescription
1
510(k) clearances
11,220
Adverse events (206 deaths)
12
Recalls
13
Facilities
Description
The AutoPulse Resuscitation System Model 100 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-13 | Jolife AB | Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justif |
| 2025-05-21 | Jolife AB | Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use. |
| 2025-03-04 | ZOLL Circulation, Inc. | AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060. |
| 2024-07-12 | Defibtech, LLC | Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or dea |
| 2022-09-22 | ZOLL Circulation, Inc. | Due to increase in Li-Ion Battery failures |
| 2018-02-13 | Michigan Instruments, Inc. | A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not deliver any compression depth to the piston during the first 5 revolutions of |
| 2013-07-16 | Zoll Circulation, Inc. | Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product. |
| 2012-08-08 | Zoll Circulation, Inc. | Complaints associated with an unexpected stop in AutoPulse compressions. |
| 2011-02-08 | Jolife AB | LUCAS 2 Chest Compression System may have malfunctions resulting from the failure of a hood probe on the device that connects to the battery. The device may stop in fail safe mode |
| 2008-01-28 | Zoll Circulation, Inc. | Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions). |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.