Device product
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
Z-1365-2022
Product summary
- Event
- Event 90423
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 38 OUS (no US distribution)
- Official record key
device-enforcement:Z-1365-2022
Official wording
Reason: The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.
Code information: Model, country, and serial number: MS20508: El Salvador DSPN-0003 Mexico DSPM-0003, DSPH-0002 Chile DSPL-0003 Saudi Arabia DSPJ-0003, DSPL-0004, DSPL-0005, DSPL-0006, DSPL-0007, DSPM-0001, DSPM-0002, DSPL-0008, DSPK-0002, DSPH-0003, DSPJ-0004, DSRA-0001 Kuwait DSPJ-0002, DSPK-0001 India DSPN-0001, DSPN-0002, DSRA-0002 Taiwan DSPL-0001, SPL-0002, DSPJ-0001 MS20509: Germany DSPH-0003 Qatar DSPL-0007, DSRB-0001 Spain DSPK-0002, DSPJ-0006, DSPJ-0003, DSPH-0001, DSPJ-0004, DSPK-0001, DSPL-0008 Hungary DSPF-0003 Belarus DSPJ-0005 United Kingdom DSPF-0002 Italy DSPJ-0002
Distribution pattern: No US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT, KW, MX, SA, SV, TW.
Derived failure modes
-
Unknown
The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.