Philips Expression MR200 MRI Patient Monitoring System recalled for metal debris risk
Check your Philips Expression MR200 MRI monitor
During manufacturing, small aluminum debris became stuck to the plastic covering on the device's pole assembly. This metal debris could prevent the system from powering on or cause it to lose power unexpectedly, which might interrupt patient monitoring and delay diagnosis.
- If you own or operate a Philips Expression MR200 (Model 866120) with lot numbers US33600006, US33600007, US33600011, US33600012, or US33600013, contact Philips or your equipment supplier immediately
- Do not use the device until you confirm it is not affected or have received instructions from the manufacturer
- Request inspection or replacement from Philips
During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2015Don't want to check this manually?
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