Z-0812-2024 Class III Ongoing
FDA device recall Z-0812-2024 was initiated by Philips North America on December 29, 2023 and is designated Class III. 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… The recall status is ongoing. Affected quantity: 7 US; 16 ROW total.
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2024
- Initiation Date
- December 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 US; 16 ROW total
Product Description
SmartPath to dStream for 1.5T, Model No. 781260, 782112
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 Pattern
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.
Code Information
Model No. 781260 UDI-DI 00884838095076 Serial Numbers 21020 9024 8657 21200 21223 18948 32131; Model No. 782112 UDI-DI 00884838098886 Serial Numbers 30089 20204