Recall Z-0691-2016— Draeger Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by Draeger Medical, Inc., initiated 2015-12-22, terminated 2017-04-05. It names 3 FDA 510(k) clearances: K103625, K082600, K062267. Product: Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.. Reason: Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating..
- Recalling firm
- Draeger Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-12-22
- Terminated
- 2017-04-05
- Firm location
- Telford, PA, United States
510(k) clearances named in this recall
3 on FDA's record- K103625 — OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE
- K082600 — OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)
- K062267 — OXYLOG 3000
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
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
Reason for recall
Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.
Data sourced from openFDA. This site is unofficial and independent of the FDA.