FDA Enforcement
Class III
Ongoing
Achieva 1.5T Conversion, Model No. 781283
Recall: Z-0808-2024
·
Reported January 31, 2024
Enforcement
- Recall Number
- Z-0808-2024
- Event ID
- 93788
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 31, 2024
- Initiation Date
- December 29, 2023
- Classification Date
- January 25, 2024
- Address
- 222 Jacobs St, N/A, Cambridge, MA, 02141-2296, United States
Description
Achieva 1.5T Conversion, Model No. 781283
Reason
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.
Code Info
Model No. 781283 UDI-DI 00884838009806 Serial Number 39016
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.
Quantity
7 US; 16 ROW total