Z-1671-2021 Class II Terminated
FDA device recall Z-1671-2021 was initiated by Philips North America Llc on February 2, 2021 and is designated Class II. Reason for recall: Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices The recall status is terminated (terminated September 20, 2022). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 2, 2021
- Initiation Date
- February 2, 2021
- Termination Date
- September 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
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.
Reason for Recall
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.
Code Information
Serial numbers: US09699788 (US) US156J6219 (US) US156J3658 (OUS) UDI: (01)00884838082236 (21)US09699788 (01)00884838082236 (21)US156J6219 (01)00884838030350 (21)US156J3658