Recall Z-0611-2014— Covidien
Class I · Terminated
Class I FDA medical device recall by Covidien, initiated 2013-12-16, terminated 2016-11-29. It names 6 FDA 510(k) clearances: K053388, K020357, K001646 and 3 more. Product: Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.. Reason: Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error..
- Recalling firm
- Covidien
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-12-16
- Terminated
- 2016-11-29
- Firm location
- Boulder, CO, United States
510(k) clearances named in this recall
6 on FDA's record- K053388 — MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
- K020357 — 800 SERIES EASYNEB NEBULIZER
- K001646 — PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
- K993071 — PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
- K984535 — PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
- K970460 — NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.
Reason for recall
Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error.
Data sourced from openFDA. This site is unofficial and independent of the FDA.