The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1792-2025·Announced 2025-05-28

Philips Upgrade to MR 7700 Medical Device Alignment Error Recall

Philips is recalling the Upgrade to MR 7700 (Model 782130) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. The misalignment could affect diagnostic accuracy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The source text describes a potential functionality issue (alignment error) with no reported illnesses or injuries documented, and the affected population is limited (13 units). This fits the Class II criteria for a moderate severity recall without hospitalization or injury reports.

Plain-English summary

Philips North America LLC is recalling the Upgrade to MR 7700, Model Number 782130, due to a potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

This issue affects 13 units total: 7 in the United States and 6 overseas. The affected devices are identified by the following serial numbers: 42030, 42066, 42151, 42211, 42248, 42376, 45001, 45007, 45236, 71613, 71907, 85643, and 85644. The UDI-DI for this product is 00884838104402.

The devices have been distributed worldwide, including to the United States and numerous international locations. Users who have received this equipment should contact Philips North America LLC for guidance on remediation options.

The recalled product

Product
Product Name: Upgrade to MR 7700; Model Number: 782130;
Manufacturer
Philips North America Llc
Category
Medical Device — Imaging Equipment / MRI
Hazard

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 (15)

  • Model Number: 782130
  • UDI-DI: 00884838104402
  • Serial Numbers: 42030
  • 42066
  • 42151
  • 42211
  • 42248
  • 42376
  • 45001
  • 45007
  • 45236
  • 71613
  • 71907
  • 85643
  • 85644

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 →

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