Model note · Defibrillator
ZOLL AED Plus and Fully Automatic AED Plus
The ZOLL AED Plus is a public access and first responder AED that runs on ten consumer 123A photo lithium cells instead of a dedicated battery pack, and its CPR-D-padz one piece electrode carries a sensor that measures compression depth and rate for Real CPR Help prompts. It gives Rectilinear Biphasic shocks at 120, 150 and 200 J in adult mode. In the US it moved from 510(k) to a PMA, P160015, approved on 26 May 2017 under the FDA order that made every AED a PMA device. Its biggest field action (2009, 183,535 units) was self test software that could miss defective batteries.
The model
Maker, model and type.
- Maker
- ZOLL Medical Corporation
- Model
- AED Plus and Fully Automatic AED Plus
- Device type
- Defibrillator
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA status | PMA P160015, approved 26 May 2017; product code MKJ (automated external defibrillator); earlier 510(k)s K011388 (2002, semi automatic) and K120406 (2012, fully automatic) | Source |
| Waveform and energy | ZOLL Rectilinear Biphasic; automatic preset sequence 120 J, 150 J, 200 J in adult mode; energy set by the electrode type connected | Source |
| Charge time | Less than 10 seconds with new batteries | Source |
| Power | 10 lithium manganese dioxide 123A photo flash cells, changed by the user | Source |
| Size, weight, protection | 13.3 x 24.1 x 29.2 cm; 3.1 kg; IP55 | Source |
| Rhythm analysis (adult test set) | Coarse VF sensitivity 100% (536 samples, goal over 90%); rapid VT 98.75% (80, goal over 75%); normal sinus rhythm specificity 99.95% (2210, goal over 99%); asystole specificity 100% | Source |
| Patient impedance range and ECG bandwidth | 0 to 300 ohm; 2 to 30 Hz | Source |
| CPR feedback | Metronome adjustable from 60 to 100 per minute; compression depth measured from 1.3 to 7.8 cm; adult electrodes only | Source |
| Children | Under 8 years or under 25 kg: use the ZOLL AED Plus pediatric electrodes; the device sets the energy from the electrode type; do not delay therapy to find the exact age or weight | Source |
| Data | Records ECG, events, device identity and optional audio; uploaded to a PC over an infrared (IrDA) port | Source |
Recalls
Known FDA recalls.
- Z-1206-20092009-02-12
Device may fail to discharge: self test software did not adequately detect defective batteries; mandatory software upgrade; 183,535 units.
FDA record - Z-0548-032002-12-17
Defibrillator may fail to function because of false detection of a safety fault condition.
FDA record
Safety
Safety warnings from the record.
- In 2009 FDA recorded that affected units could fail to discharge because the self test did not adequately detect defective batteries; the fix was a mandatory software upgrade. Source
- Do not touch the patient during analysis or shock; listed adverse effects include bystander shock and skin burns at the pad sites. Source
- In the Fully Automatic model the shock is delivered without pressing a button after a countdown; responders must be told which model is on the wall. Source
Sources
Where this note comes from.
- FDA Summary of Safety and Effectiveness Data, PMA P160015, AED Plus and Fully Automatic AED Plus
- ZOLL AED Plus Administrator-Handbuch, 9650-0301-08 Rev. G (2011), third-party hosted copy
- openFDA device recall and MAUDE records for the AED Plus
Not covered: Specifications come from a 2011 German edition of the Administrator's Guide hosted by a university, not from ZOLL directly; check them against the current English guide. ZOLL does not publish a numbered error code list for this model; troubleshooting is by voice prompt and status window. The approved battery brands may have changed since 2011. Pediatric energy values are not stated here because the source table was not legible.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Defibrillator