High FDA (Devices)·Z-1805-2025·Announced 2025-05-28

Philips MR 7700 Medical Device Alignment Error in MobiView Application

Philips is recalling MR 7700 model medical devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a medical device with a functional error that could affect diagnostic image interpretation. The source text does not report any illnesses or injuries, but the alignment error in image review functionality presents a risk of harm through potential misdiagnosis.

Plain-English summary

Philips North America LLC is recalling the MR 7700 medical device, model numbers 782120 and 782153, due to a potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

The affected devices are identified by specific serial numbers and have been distributed worldwide, including in the United States and numerous other countries. A total of 72 units have been distributed (6 in the US and 66 outside the US).

Users who have this device should contact Philips North America LLC for instructions on addressing this issue.

The recalled product

Product: Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Manufacturer: Philips North America Llc
Category: Medical Device — Imaging Equipment
Hazard: alignment-error
image-quality-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model Numbers: (1) 782120
(2) 782153
UDI-DI: (1) 00884838104112
(2) 00884838112858
Serial Numbers: (1) 65000
65001
65002
65003
65004
65005
65007
65008
65009
65011
65012
65013
65014
65017
65018
65019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 18 products in this recall →

Same manufacturer · Philips North America Llc

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