SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Sy

FDA device recall Z-2163-2024 · posted 2024-06-27 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

Potential for coils to heat up and harm patients (burn).

Action taken

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 pd.cnr@philips.com. 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.

Root cause

Device Design

Status

Open, Classified

Product code

MOS

Quantity affected

729 units

Distribution

Worldwide distribution: US (Nationwide) and OUS (Foreign): Afghanistan, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, C

Date initiated

2024-06-05

Date posted

2024-06-27

Location

Cambridge, MA

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