International safety notice
URGENT - Field Safety Notice - Use of auto servo ventilation (ASV) devices on patients with symptomatic chronic heart failure (NYHA 2-4) and reduced LVEF≤45%, AND moderate to severe predominant central sleep apnea, Philips
Germany / BfArM · DEU · May 26, 2015
Key facts
| Title | URGENT - Field Safety Notice - Use of auto servo ventilation (ASV) devices on patients with symptomatic chronic heart failure (NYHA 2-4) and reduced LVEF≤45%, AND moderate to severe predominant central sleep apnea, Philips |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | URGENT - Field Safety Notice - Use of auto servo ventilation (ASV) devices on patients with symptomatic chronic heart failure (NYHA 2-4) and reduced LVEF≤45%, AND moderate to severe predominant central sleep apnea, Philips |
| Manufacturer | URGENT - Field Safety Notice - Use of auto servo ventilation (ASV) devices on patients with symptomatic chronic heart failure (NYHA 2-4) and reduced LVEF≤45%, AND moderate to severe predominant central sleep apnea, Philips |
| Models | LVEF≤45, HR=1.335, 1.666, 387‐3311, 1.070, 0.010 |
| Date | May 26, 2015 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1