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MEDRAD® 3.0T eCoil Imaging System (for Philips)

BAYER MEDICAL CARE INC. · Model 4522-132-63981 · UDI-DI 00616258009100

MOS Prescription
1
510(k) clearances
136
Adverse events
38
Recalls
76
Facilities

Description

"3.0TeCOIL INTERFACE DEVICE PHILIPS ACHIEVA (60727331)"

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.