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Sign in to claim this brandZoll Medical Corporation
United States·US-MF-000021386
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 269, Mill Road, Chelmsford, United States
- Website
- www.zoll.com
- —
- —
- [email protected]
- Phone
- +19784219655
- PRRC Contact
- Paul Dias
- EUDAMED SRN
- US-MF-000021386
- FDA FEI Number
- 1218058
- DUNS Number
- 055363428
Catalogue (3247)
Page 1 of 65| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| bellavista Accessories | 304.585.001-40 | EUDAMED | Class I | Active |
| Zenix ECG Accessories | 8016-000629-12 | EUDAMED | Class I | Active |
| Zenix Defibrillation Accessories | 8300-0803-12 | EUDAMED | Class I | Active |
| Zenix Defibrillation Accessories | 8016-000593 | EUDAMED | Class I | Active |
| Zenix Defibrillation Accessories | 8300-0804-12 | EUDAMED | Class I | Active |
| 90210200499991110 | 90210200499991110 | EUDAMED | Class IIb | Active |
| R Series | 30001007201310013 | FDA UDI | Class III | Active |
| R Series | 10120000001110012-1 | FDA UDI | Class III | Active |
| X Series | 630-2231211-01-68 | FDA UDI | Class II | Active |
| M Series | 60021311000103010 | FDA UDI | Class III | Active |
| E Series | 80000310010124013 | FDA UDI | Class III | Active |
| E Series | 50011810020024014 | FDA UDI | Class III | Active |
| R Series | 30000000001130012 | FDA UDI | Class II | Active |
| X Series | 601-2441511-01-66 | FDA UDI | Class III | Active |
| X Series | 620-2120001-01 | FDA UDI | Class II | Active |
| Internal Handle | 1011-0141-05 | FDA UDI | Class II | Active |
| X Series | 610-0221011-01 | FDA UDI | Class II | Active |
| Patient Circuits | 499-0019-01 | FDA UDI | Class II | Active |
| M Series Biphasic | 40010011100003010 | FDA UDI | Class II | Active |
| R Series | 30001001001130013 | FDA UDI | Class II | Active |
| M Series | 60010011000003011 | FDA UDI | Class III | Active |
| Aed Plus | 70010400499991010 | FDA UDI | Class III | Active |
| M Series Biphasic | 40021211100023010 | FDA UDI | Class II | Active |
| X Series | 630-2130111-01 | FDA UDI | Class II | Active |
| X Series | 600-0240011-01 | FDA UDI | Class II | Active |
| X Series | 620-1221511-01 | FDA UDI | Class II | Active |
| Aed Plus | 8000-004008-01 | FDA UDI | Class III | Active |
| X Series | 620-2221010-01-66 | FDA UDI | Class II | Active |
| X Series | 620-0240011-01 | FDA UDI | Class II | Active |
| X Series | 601-2230411-01 | FDA UDI | Class III | Active |
| R Series | 10001000001110012 | FDA UDI | Class II | Active |
| Powerheart G5 Automatic AED | G5A-01-L | FDA UDI | Class III | Active |
| X Series | 630-2431112-01 | FDA UDI | Class II | Active |
| X Series | 600-2221510-01-66 | FDA UDI | Class II | Active |
| R Series | 10000005201310012 | FDA UDI | Class II | Active |
| M Series | 60010311000103010 | FDA UDI | Class III | Active |
| X Series | 600-0220510-01 | FDA UDI | Class II | Active |
| Resqpod Itd 10 | 12-0242-000 | FDA UDI | Class II | Active |
| Ecg | 9600-0230 | FDA UDI | Class II | Active |
| Pedi-Padz | 8900-2500-01 | FDA UDI | Class III | Active |
| R Series | 30000001001130012 | FDA UDI | Class III | Active |
| M Series Biphasic | 60010010100010013 | FDA UDI | Class II | Active |
| X Series | 620-2220011-01 | FDA UDI | Class II | Active |
| Internal Handle | 1011-0141-03-08 | FDA UDI | Class II | Active |
| X Series | 601-2220112-01 | FDA UDI | Class III | Active |
| X Series | 620-2221011-01 | FDA UDI | Class II | Active |
| E Series | 50001040010164012 | FDA UDI | Class III | Active |
| E Series | 50001730020174013 | FDA UDI | Class III | Active |
| R Series | 10000001001110012 | FDA UDI | Class II | Active |
| M Series | 40010211110163010 | FDA UDI | Class III | Active |
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FDA Recalls (16)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 13, 2025 | Z-1320-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1319-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1323-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1322-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1318-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1321-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1317-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1316-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| May 31, 2024 | Z-2324-2024 | — | open, classified | G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest |
| Apr 30, 2024 | Z-2130-2024 | — | open, classified | Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy |
| Mar 5, 2014 | Z-1311-2014 | — | terminated | Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used |
| Aug 16, 2012 | Z-2401-2012 | — | terminated | Shipped with incorrect software |
| Apr 21, 2011 | Z-2294-2011 | — | terminated | Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy |
| Aug 2, 2004 | Z-1472-04 | — | terminated | Visual Sreen display and audible prompt may not advise to 'Press Shock' |
| Jun 23, 2003 | Z-1000-03 | — | terminated | Defibrillator may fail to charge or hold its charge above energies of 75 joules |
| Dec 17, 2002 | Z-0548-03 | — | terminated | Defibrillator may fail to function due to false detection of safety fault condition |