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Coil Fixation Plate short

Noras MRI products GmbH · Model 01 · UDI-DI 04251269205156

MOS Prescription
1
510(k) clearances
136
Adverse events
38
Recalls
77
Facilities

Description

The intended use of the Noras OR Head holder is the fixation of the human skull just before, during and at the end of the intervention in the operating room.

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.