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WristView

ASPECT IMAGING LTD · Model WristView · UDI-DI 00858755006101

MOSLNH Prescription
10
510(k) clearances
136
Adverse events
38
Recalls
78
Facilities

Description

The Wrist\\view MRI System is a 1T Permanent magnet MRI scanner. It is indicated for Wrist and Hand imaging. The imaging volume is an ellipsoid with dimensions of 120mm X 120 mm X 70mm around the magnet center. The overall dimensions of the magnet assembly are 140 cm x 100 cm x 235 cm [with patient trolley].

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.