Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The… — Class II medical device recall Z-2401-2012
Terminated recall by ZOLL Medical Corporation, reported 2012-09-26, distributed nationwide. Shipped with incorrect software
| Recall number | Z-2401-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ZOLL Medical Corporation, Chelmsford, MA, United States |
| Recall initiated | 2012-08-16 |
| Classified | 2012-09-17 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2012-09-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Quantity | 11 units |
| Reason classes | software |
| Serial numbers | AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944, AR12F001100, AR12F001298 |
Product
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG).
Reason for recall
Shipped with incorrect software
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2401-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.