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Template Holder with Fiducials
Promaxo, Inc. · Model 19610 · UDI-DI 00850042098165
MOS
Prescription
10
510(k) clearances
136
Adverse events
38
Recalls
78
Facilities
Description
The Promaxo Template Holder with Fiducials (PN 19610) is a two-channel, receive-only MRI coil intended for use with the Promaxo MRI System (Models PR071-001-M and PR071-001-R).
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.