International safety notice
Urgent Field Safety Notice for Amara View Minimal Contact Full-Face Mask (Full Face Mask); DreamWear Full Face Mask (Full Face Mask); DreamWisp Nasal Mask with Over the Nose Cushion (Nasal Mask); Wisp Nasal Mask (Nasal Mask); Wisp Youth Nasal Mask (Nasal Mask); by Respironics, Inc. Pittsburgh
Germany / BfArM · DEU · Sep 9, 2022
Key facts
| Title | Urgent Field Safety Notice for Amara View Minimal Contact Full-Face Mask (Full Face Mask); DreamWear Full Face Mask (Full Face Mask); DreamWisp Nasal Mask with Over the Nose Cushion (Nasal Mask); Wisp Nasal Mask (Nasal Mask); Wisp Youth Nasal Mask (Nasal Mask); by Respironics, Inc. Pittsburgh |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | Amara View Minimal Contact Full-Face Mask (Full Face Mask); DreamWear Full Face Mask (Full Face Mask); DreamWisp Nasal Mask with Over the Nose Cushion (Nasal Mask); Wisp Nasal Mask (Nasal Mask); Wisp Youth Nasal Mask (Nasal Mask); |
| Manufacturer | Respironics, Inc. Pittsburgh |
| Models | 1120434, 1137938, 1137430, 1133423, 1137943AP, 1133436, 1145038, 1133413, 1145074, 1137944CE, 1145052, 1145062 and 256 more |
| Date | Sep 9, 2022 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 100–999 Matching catalog numbers in FDA data
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