SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
Recall
- Recall Number
- Z-2165-2024
- Event Number
- 94786
- Firm
- Philips North America Llc
- FEI Number
- 3016618143
- Product Code
- MOS
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- June 5, 2024
- Posted
- June 27, 2024
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289
Description
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
Potential for coils to heat up and harm patients (burn).
An URGENT MEDICAL DEVICE RECALL notice, dated 5/31/24, was mailed to consignees. The notice instructs users to follow the provided instructions when operating a MR system with affected coils. These instructions include avoiding First Level Operating Mode/High SAR scans, use dedicated pads and mattresses provided with the coils. avoid positioning the coil closer than 2 inches (5 cm) from the bore, and do not exceed 45 minutes of examination time. An Advisory Notice that summarizes the recommended actions was provided with the recall notification and is to be displayed with affected systems to ensure access by operators. The recall notification is to be circulated among users of affected systems. The completed response form is to be returned to Philips by email at [email protected]. Philips is developing field corrections in response to this recall that include potential software risk control measures to limit scan settings when using the coils, hardware updates, and improving the design of the coil. Philips intends to update consignees on these actions by the end of 2024. Consignees with any questions can contact the Customer Care Solutions center from 8:00 AM to 8:00 PM from Monday through Friday at 1-800-722-9377. An updated letter was mailed to consignees on about 12/11/2024. The contained the same information but provided an update on Philips actions which include: 1. Warning label for coil and pad: Per your response form Philips will contact you to schedule time for a Field Service Engineer (FSE) to visit your site to apply a warning label to the coil and pad starting in January 2025. (Ref 78100607); 2. Instruction For Use (IFU) Update: Including additional warnings and illustrations Q2 2025.
Worldwide distribution: US (Nationwide) and OUS (Foreign): Afghanistan, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Papua New Guinea, Peru, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, T¿rkiye, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam.
14 units