Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neon

FDA device recall Z-0497-2019 · posted 2018-12-18 · Terminated

Recall details

Recalling firm

COVIDIEN LLC

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

Action taken

Medtronic notified U.S. consignees notified via Federal Express or certified mail on September 19, 2018, and the letter informs customers that Medtronic has developed a software update, Maintenance Release (MR) 5.4. Medtronic Service Engineers will load the MR5.4 software during the next scheduled or planned maintenance visit. Immediately notify all care environments in which the PB980 ventilators are used about this notification. " If your facility has distributed PB980 ventilators to other persons or facilities, please promptly forward a copy of this letter to those recipients. " Complete the attached form and return it as directed to confirm your receipt and understanding of this information. Any incidents related to this issue or if you have any questions, please contact our Technical Support Department immediately at 1-800-255-6774. Out--Side US accounts notified by Medtronic Regulatory Partners worldwide on 9/17/18 for translation in their respective country.

Root cause

Device Design

Status

Terminated

Product code

CBK

Quantity affected

9,593

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 G

Date initiated

2018-09-18

Date posted

2018-12-18

Date terminated

2021-02-01

Location

Mansfield, MA

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