FDA Device recall Z-1784-2022
Therapy Mask 3100 NC/SP
- FDA Device
- Class I
- ongoing
- Published 2022-10-12
On 2022-10-12 the FDA classified a Class I recall of Therapy Mask 3100 NC/SP by Philips Respironics, citing no contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1784-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-09-06 |
| Published | 2022-10-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Respironics |
| Distribution | US |
Product
Therapy Mask 3100 NC/SP
Reason
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
Identifiers
| code_info | All Units; Model No.: 1144608, 1144610, 1145038, 1145039, 1145040, 1145041, 1145044, 1145045, 1145046, 1145047, 1145048…All Units; Model No.: 1144608, 1144610, 1145038, 1145039, 1145040, 1145041, 1145044, 1145045, 1145046, 1145047, 1145048, 1145049, 1145050, 1145051, 1145052, 1145055, 1145056, 1145057, 1145058, 1145059, 1145060, 1145061, 1145062, 1145063, 1145064, 1145065, 1145066, 1145067, 1145068, 1145069, 1145070, 1145071, 1145072, 1145073, 1145074, 1145459, 1145460, 1145461, 1145462, 1145463, 1145464, 1145465, 1145466, 1145467, 1145478, 1145916, 1145917. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1784-2022%22
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