Class III

Medical Device Recall: Achieva 1.5T Conversion, Model No. 781283

Philips North America · December 29, 2023

Reason for Recall

An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.

Distribution

Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.

States Affected

NATIONWIDE

Quantity Affected

7 US; 16 ROW total

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0808-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.