Philips PIIC Classic Upgrade Patient Monitor Recall for ECG Waveform Misrepresentation
Philips is recalling PIIC Classic Upgrade patient monitors because reconstructed ECG leads may misrepresent waveforms on the Information Center iX.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could misrepresent clinical data (ECG waveforms), posing a risk of harm through potential misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling the Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm). The recall involves 5,569 units that were distributed nationwide in the United States and in numerous countries worldwide, including 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.
The recall is due to a software issue (Software B.O) where reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. This misrepresentation could potentially affect the accuracy of the displayed or printed ECG data.
Healthcare facilities and users of these monitors should contact Philips Electronics North America Corporation for further instructions on how to address the software issue. The agency has classified this recall as Class II.
The recalled product
- Product
- Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
- Affected units
- 5,569
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software B.O
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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