ZOLL 731 Series Ventilators Recalled for Software Anomaly
ZOLL Medical Corporation is recalling 46 units of 731 Series Ventilators due to a software anomaly that may allow users to inadvertently change device settings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a software defect could lead to unintended changes in settings for patients with respiratory failure. This fits the rubric for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or illnesses are cited in the source text.
Plain-English summary
ZOLL Medical Corporation is recalling 46 units of 731 Series Ventilators (Models EMV+, AEV, Eagle II, and Eagle II MRI) running software version 05.20.00. The recall is due to a software anomaly that can lead to a user inadvertently changing device settings.
The affected devices are indicated for use in the management of infant through adult patients weighing 5 kg or more with acute or chronic respiratory failure or during resuscitation. The ventilators are designed for use in hospitals, outside the hospital, during transport, and in severe environments. The distribution pattern for this recall is listed as outside the US.
Consumers and healthcare providers should contact ZOLL Medical Corporation for further instructions on how to address the software anomaly. No specific instructions for immediate action are provided in the source text beyond the identification of the defect.
The recalled product
- 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…
- Manufacturer
- ZOLL Medical Corporation
- Category
- Medical Device — Ventilators
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Models EMV+
- AEV
- Eagle II
- and Eagle II MRI
Distribution
Distribution scope not specified by the agency.
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