FDA Enforcement
Class II
Terminated
Philips Healthcare IntelliVue Info Center iX, A.0 866023
Recall: Z-0856-2016
·
Reported March 2, 2016
Enforcement
- Recall Number
- Z-0856-2016
- Event ID
- 72720
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Electronics North America Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 2, 2016
- Initiation Date
- November 25, 2015
- Classification Date
- February 23, 2016
- Termination Date
- September 6, 2017
- Address
- 3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States
Description
Philips Healthcare IntelliVue Info Center iX, A.0 866023
Reason
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
Code Info
Software A.0.X
Distribution
Worldwide Distribution-US (nationwide) and the countries of Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.
Quantity
5671 units