# FDA 483 - Zoll Medical Corporation - June 13, 2022

Source: https://www.keypedia.com/records/483/zoll-medical-corporation/1ba8f4ba-d9c9-44ad-bed4-470b47497f65

> FDA 483 for Zoll Medical Corporation on June 13, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zoll Medical Corporation
- Inspection Date: 2022-06-13
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: ZOLL Medical Corporation in Deerfield, WI, received a Form FDA 483 with five observations, two of which were repeat observations from a 2016 inspection. The observations primarily concern significant deficiencies in the firm's quality system, particularly regarding corrective and preventive actions, complaint handling, medical device reporting, and risk management for their Class III Powerheart G5 AED, which has a critical error code 501 linked to patient death. The firm also failed to adequately approve purchasing data for a critical device component.

## Related Officers

- [investigator](https://www.keypedia.com/people/nicholas-t-domer/8e2d2ff5-b0da-4b0d-bd65-492a49ae1035)

Company: https://www.keypedia.com/companies/zoll-medical-corporation/7f755d0e-4682-4cfd-8387-47834c0612a2

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d