SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782112; 2) 781260
This recall is currently active, issued September 20, 2024. It was issued by Philips North America Llc.
- Company
- Philips North America Llc
- Recall Initiated
- September 3, 2024
- Posted
- September 20, 2024
- Recall Number
- Z-3203-2024
- Quantity
- 32 units
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Maldives, Mauritius, Mexico, Morocco, Netherlands, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam.
Lot / Code Info
Model UDI-DI: 782112 (01)00884838098886(21); 781260 (01)00884838095076(21). Serial Numbers; 8876 10190 10521 13021 13023 18520 18892 18942 20159 21127 21158 21513 21726 21803 22027 22048 22093 22247 30054 30273 32250 32355 32412 32419 32469 32539 32724 32827 33371 33639 39070 75067
Root Cause
Under Investigation by firm
Action Taken
Philips issued URGENT Medical Device Correction dated 8/23/24 to US consignees via Fed'x. Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: A. Customers can continue using identified systems in accordance with the intended use. B. As a reminder, when using MR systems, follow the warnings listed in the IFU provided with your system: Refer to the warnings listed in the IFU section titled Moving the patient into the magnet bore: " Before starting a scan which initiates tabletop movement, always check that nothing can get caught or hit during tabletop movement. " Check patient, patient extremities, clothing, equipment and positioning aids. Guide cables and intravenous lines " Due care must be taken to ensure that no part of the patient's body, hair, clothing cables or infusion lines can be trapped or injured by any part of the equipment. C. If you experience resistance from the tabletop movement during patient scan, Stop-use immediately and contact your local Philips service representative. D. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. E. Please display attached Advisory with your system(s); ensure the notice is in a place likely to be seen/viewed by operators. F. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt via email to: Philips.Recall@philips.com. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 5. The actions planned by Philips to correct the problem Philips will contact you to schedule time for a Field Service Engineer (FSE) to visit your site to inspect the IRF carrier assembly and provide a correction if necessary (reference FCO78100588). Philips plans to start implementing corrections in Q4 2024. If you need a