SmartPath to dStream for 1.5T, Model No. 781260, 782112
This recall is currently active, issued January 25, 2024. It was issued by Philips North America.
- Company
- Philips North America
- Recall Initiated
- December 29, 2023
- Posted
- January 25, 2024
- Recall Number
- Z-0812-2024
- Quantity
- 7 US; 16 ROW total
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
On December 29, 2023, the firm notified affected customers with URGENT Medical Device Correction letters. The firm stated there is no impact to patients or users. There is a potential risk of electrical shock for service personnel. Customers may continue to use MR systems in accordance with the intended use. Circulate this notice to all users of this device so that they are aware of the issue, and post the letter in the technical room until the electrical shock warning label is updated. A Philips representative will contact you to schedule a time for a Field Service Engineer to verify the electrical shock warning label and apply the correct label if applicable. If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).