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3T 32Ch Torso Coil - Anterior

NEOCOIL, LLC · Model 02 · UDI-DI 00856181003022

MOS Prescription

510(k) clearances

136

Adverse events

Recalls

Facilities

Description

The NeoCoil 3.OT 32-Channel Torso Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging Systems. The coil consists of 2 antenna arrays; a posterior and an anterior. The posterior array contains 17 elements to achieve 16 channels and is enclosed in a rigid housing. The anterior array also contains 17 elements to achieve the later 16 channels but is enclosed in a flexible housing. The coil is wrapped around the patient's torso with hook and loop straps. The NeoCoil 3.0T 32-Channel Torso Array Coil is for use with the GE S.OT HD Series MR System (K052293)

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.