Invivo Recalls Philips MRI Patient Monitoring Systems Due to Metal Debris
Invivo is recalling 10 Philips MRI Patient Monitoring Systems because metal debris found during production could cause power failures and loss of patient 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 medical device where a failure could result in the loss of patient monitoring and delayed diagnosis, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Invivo Corporation is recalling 10 units of the Philips Expression MR200 MRI Patient Monitoring System, Model 866120. The affected units are identified by lot numbers US33600006, US33600007, US33600011, US33600012, and US33600013.
The recall was initiated because excess aluminum debris was found stuck to the cling plastic covering the device's pole assembly during production. This metallic debris poses a risk of system performance issues, specifically the potential for the device to fail to power up or to lose power. Such failures could result in the loss of patient monitoring and a delay in patient diagnosis.
The affected devices were distributed worldwide, including in the United States (California) and in Poland, Singapore, and Sweden. Users of these devices should contact Invivo Corporation for further instructions regarding the recall.
The recalled product
- Product
- Philips Expression MR200 MRI Patient Monitoring System Model 866120
- Manufacturer
- Invivo Corporation
- Affected units
- 10
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 (4)
- Model 866120 with the following lots #'s: US33600006
- US33600007
- US33600011
- US33600012 and US33600013
Distribution
Distributed in 1 state:
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