Class II — ZOLL Medical Corporation
| Recalling firm | ZOLL Medical Corporation |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings. |
| Product | 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environment… |
| Quantity | 46 |
| Distribution | Outside US |
| Initiated | 2017-06-30 |
| Classified | 2018-03-01 |
| Terminated | 2018-10-09 |
| Recall number | Z-0812-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ZOLL Medical Corporation (Z-0812-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79248/
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