Device product
Phantom 2 Nasal Vented Mask
Z-1357-2024
Product summary
- Event
- Event 94169
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 2417 units
- Official record key
device-enforcement:Z-1357-2024
Official wording
Reason: Update to contraindications and warning language due to CPAP masks containing magnets.
Code information: All UDI-DI; All Lot Numbers.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of AUSTRIA, BAHRAIN, BRAZIL, COLOMBIA, COSTA RICA, ECUADOR, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, INDIA, IRAQ, IRELAND, ISRAEL, ISREAL, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NORWAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SULTANATE OF OMAN, SWEDEN, SWITZERLAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VIETNAM, YEMEN.
Derived failure modes
-
Unknown
Update to contraindications and warning language due to CPAP masks containing magnets.