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1.5T 8ch Shoulder Coil

NEOCOIL, LLC · Model 04 · UDI-DI 00856181003046

MOS Prescription
1
510(k) clearances
136
Adverse events
38
Recalls
76
Facilities

Description

The NeoCoil 1 ST 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 greater SNR due to its unique eight channel layout and a larger field-of-view due to the antenna layout.

Recalls

DateFirmReason
2024-11-04Philips North America LlcPotential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04Philips North America LlcPotential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04Philips North America LlcPotential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04Philips North America LlcPotential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04Philips North America LlcPotential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04Philips North America LlcPotential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04Philips North America LlcPotential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04Philips North America LlcPotential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04Philips North America LlcPotential safety issue where a patient may be harmed while preparing for or during a scan.
2024-11-04Philips North America LlcPotential 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.