# FDA recall Z-0497-2019

> **COVIDIEN LLC** · Class I · device recall initiated 2018-09-18.

## Product

Puritan Bennett 980 (PB980) ventilator series:  Puritan Bennett" 980 Pediatric   Adult Ventilator  Puritan Bennett" 980 Neonatal Ventilator  Puritan Bennett" 980 Universal Ventilator    Product Usage:  The Puritan Bennett  980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively, to patients who require the followingtypes of ventilator support:   Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs).

## Reason for recall

Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation

## Distribution

Worldwide Distribution - US Nationwide  Foreign:  Canada  Argentina  Chile  Japan  Hong Kong  Taiwan  Uruguay  Austria  Austria  Azerbaijan  Belgium  Bosnia And Herzegovina  Bulgaria  Croatia  Czech Republic  France  Germany  Greece  Hungary  Ireland  Israel  Italy  Kazakhstan  Kenya  Kuwait  Latvia  Lebanon  Lithuania  Netherlands  Oman  Pakistan  Poland  Portugal  Romania  Russian Federation  Saudi Arabia  Slovakia  Slovenia  South Africa  Spain  Sweden  Switzerland  Tunisia  Turkey  United Arab Emirates  Iran  United Kingdom

## Key facts

- **Recall number:** Z-0497-2019
- **Recalling firm:** COVIDIEN LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-18
- **Report date:** 2018-12-26
- **Termination date:** 2021-02-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0497-2019

## Citation

> AI Analytics. FDA recall Z-0497-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0497-2019. Source: US FDA. Licensed CC0.

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