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ROSC-U, Battery Control Unit
RESUSCITATION INTERNATIONAL, LLC · Model A03-1B-000 · UDI-DI 00860000876216
DRM
Prescription
10
510(k) clearances
11,220
Adverse events (206 deaths)
12
Recalls
13
Facilities
Description
Battery Control Unit
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.