Puritan Bennett 980 Ventilator Recalled for Touchscreen and Ventilation Issues
Medtronic is recalling 1,864 Puritan Bennett 980 ventilators worldwide due to unresponsive touchscreens and potential loss of primary ventilation.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device that provides life-sustaining ventilation; the potential loss of primary ventilation represents a significant risk of harm to patients.
Plain-English summary
Medtronic, formerly known as Covidien Respiratory and Monitoring Solutions, is recalling 1,864 units of the Puritan Bennett 980 (PB980) Ventilator System. The recall covers all models and all versions of the software. These devices are intended to provide continuous ventilation for pediatric and adult patients requiring invasive or non-invasive ventilation.
The recall was issued due to a field corrective action notice identifying two specific issues: the graphical user interface (GUI) may be unresponsive to touch, and the device may experience a loss of primary ventilation under certain circumstances. The affected units were distributed worldwide, including the United States (including Puerto Rico) and numerous international locations such as Ireland, Jordan, Saudi Arabia, Australia, Japan, and Brazil.
Healthcare facilities and users should contact Medtronic for further instructions regarding the field corrective action. The source text does not specify a particular action for consumers, as these are medical devices used in clinical settings.
The recalled product
- Product
- Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.
- Category
- Medical Device — Ventilator
- Affected units
- 1,864
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 (1)
- all versions of software.
Distribution
Distributed in 1 state:
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