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Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®)

DXTX MEDICAL INC · Model BPX 30 · UDI-DI 00850011472170

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

Description

Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®), alternate Philips package catalog number 4522-132-64752 for box of 5

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.