Z-0497-2019 Class I Terminated
Recalled by COVIDIEN LLC
— Mansfield, MA
FDA device recall Z-0497-2019 was initiated by COVIDIEN LLC on Sep 18, 2018 and is designated Class I. 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 The recall status is terminated (terminated Feb 1, 2021). Affected quantity: 9,593.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2018
- Initiation Date
- Sep 18, 2018
- Termination Date
- Feb 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,593
Product Description
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). Assist/ Control, SIMV or Spontaneous modes of ventilation
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 Pattern
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
Code Information
Serial Numbers: 35B1300001 through 35B1300051 35B1400003 through 35B1402216 35B1500001 through 35B1502227 35B1600001 through 35B1601408 35B1700001 through 35B1702519 35B1800001 through 35B1801541 35B1400001 35B1601182, 35B1601183, 35B1601193, 35B1601197, 35B1601242 35B1601243, 35B1601245, 35B1702479, 35B1601001, 35B1601089
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0497-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.