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XENOVIEW 3.0T Chest Coil

Polarean, Inc. · Model Rev C · UDI-DI 00850045949044

MOS Prescription

510(k) clearances

134

Adverse events

Recalls

Facilities

Description

The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 129Xe frequency on a 3.0T MRI magnetic field in order to image 129Xe nuclei while the patient is positioned inside a compatible multi-nuclear-capable MRI scanner. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 129Xe gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 129Xe in the lungs. The coil is constructed of a durable, flexible circuit board material within which the antenna elements and all electronic components are contained. These components are electrically isolated from the rest of the coil packaging by being enclosed within suitable non-conductive, water-rated, and flame-rated materials. A layer of padding is located on either side of the coil circuitry to provide patient comfort and protection against potential heating generated by circuitry components. The RF coil is a “fixed matching and tuning device” (i.e. not tunable by the operator), thereby eliminating the need to tune and match it for every patient.

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.