Device product
Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Z-0857-2016
Product summary
- Event
- Event 72720
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5569 units
- Official record key
device-enforcement:Z-0857-2016
Official wording
Reason: Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
Code information: Software B.O
Distribution pattern: 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.
Derived failure modes
-
Unknown
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.