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Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®)

DXTX MEDICAL INC · Model BPX 15 · UDI-DI 00850011472149

LNH Prescription
1
510(k) clearances
4,751
Adverse events (37 deaths)
699
Recalls
145
Facilities

Description

Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®), alternate Philips package catalog number 4522-132-70682 for box of 5

Recalls

DateFirmReason
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction

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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.