Device product
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Z-1671-2021
Product summary
- Event
- Event 87829
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1671-2021
Official wording
Reason: Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Code information: Serial numbers: US09699788 (US) US156J6219 (US) US156J3658 (OUS) UDI: (01)00884838082236 (21)US09699788 (01)00884838082236 (21)US156J6219 (01)00884838030350 (21)US156J3658
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.
Derived failure modes
-
Unknown
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices