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DuoFLEX® Coil Suite

M R Instruments, Inc. · Model FC3000S-8R · UDI-DI 00857371006281

MOS Prescription

510(k) clearances

134

Adverse events

Recalls

Facilities

Description

The 10cm Left Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 3000S-8R DuoFLEX® Coil Suite includes two different sets of coil paddles and a single, shared preamplifier box with a system connector. The first coil set consists of two 24cm foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. The second coil set consists of two 10cm square foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. All of these paddles connect to the same preamplifier box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 4 or 8 channels for imaging.

Recalls

Date	Firm	Reason
2024-11-04	Philips North America Llc	Potential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04	Philips North America Llc	Potential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04	Philips North America Llc	Potential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04	Philips North America Llc	Potential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04	Philips North America Llc	Potential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04	Philips North America Llc	Potential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04	Philips North America Llc	Potential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04	Philips North America Llc	Potential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04	Philips North America Llc	Potential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04	Philips North America Llc	Potential safety issue where a patient may be harmed while preparing for or during a scan.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.