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3T 8ch Shoulder Coil

NEOCOIL, LLC · Model 05 · UDI-DI 00856181003053

MOS Prescription

510(k) clearances

136

Adverse events

Recalls

Facilities

Description

The NeoCoil 3.OT 8-Channel Shoulder Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the shoulder in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers easier patient setup and greater SNR due to its compatibility with 3.OT MRI scanners. The submitted device consists of semi-flexible foam covered housing, consisting of eight antennas. The antennas are uniquely positioned with the appropriate overlap to cancel out mutual coupling effects from adjacent antennas or decoupled from an adjacent antenna using a transformer. Pre-amplifier decoupling reduces any remaining decoupling between the antennas. The coil is held in place over the imaging area via a cross body strap. A system interface cable connects to the coil at the top of the housing. The flexible foam covered housing along with the body strap enable the proper positioning on the patient before laying down and holds the coil in place while scanning is being performed. To ensure safety, each antenna is equipped with active and passive transmit decoupling circuits. Active decoupling is achieved via diodes that receive signals from the scanner to turn the coil to a high impedance state during system RF transmit. Crossed diodes are installed on each antenna acting as passive switches. These passive switches provide additional safety in case the active circuitry does not receive signal from the scanner.

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.