Invivo Recalls Philips Expression MR200 MRI Patient Monitoring Systems
Invivo Corporation is recalling 20 Philips Expression MR200 MRI Patient Monitoring Systems due to capacitor shorts that may cause electrical shock or loss of monitoring.
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 risk of electrical shock and loss of patient monitoring, which are significant hazards, but no injuries or illnesses have been reported, placing it in the High category per the rubric.
Plain-English summary
Invivo Corporation is recalling 20 units of the Philips Expression MR200 MRI Patient Monitoring System. The recall was initiated because the devices failed initial power-up tests due to capacitor shorts and high-potential testing failures.
The affected devices are distributed in the United States (California, Florida, Indiana, Kentucky, Minnesota, North Carolina, New Jersey, New York, Oklahoma, South Dakota, and Texas) and internationally in the Netherlands, Poland, and the United Kingdom. The specific model number is 866120, and the affected serial numbers range from US33600065 to US33600094.
The hazard associated with this recall is the possible loss of patient monitoring or electrical shock to the user or service personnel. Users should contact Invivo Corporation for further instructions on how to proceed with the recall.
The recalled product
- Product
- Philips Expression MR200 MRI Patient Monitoring System.
- Manufacturer
- Invivo Corporation
- Affected units
- 20
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 (20)
- Model No. 866120
- Lot/ Serial Numbers: US33600065
- US33600066
- US33600075
- US33600077
- US33600078
- US33600079
- US33600080
- US33600081
- US33600082
- US33600083
- US33600084
- US33600086
- US33600087
- US33600088
- US33600089
- US33600090
- US33600091
- US33600092
- US33600093
Distribution
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