FDA recall Z-0807-2024

Philips North America · Class III · device

Product

Achieva 1.5T, Model No. 781178, 781196, 781296

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.

Key facts

Status
Ongoing
Initiation date
2023-12-29
Report date
2024-01-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0807-2024