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OR Head Holder LUCY with HeadCoilSet Philips 1.5T
Noras MRI products GmbH · Model 01 · UDI-DI 04251269205811
1
510(k) clearances
136
Adverse events
38
Recalls
78
Facilities
Description
The NORAS OR Head Holder LUCY is used for intra-operative imaging in the X-ray or CT environment. Together with the NORAS OR head coils 1.5T/3T the head holder LUCY is used for intra-operative MR imaging during neurosurgery on the open skull.
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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Get your free API keyRead the docsData 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.
