The Recall Desk
ModerateFDA (Devices)·Z-0865-2026·Announced 2025-12-10

Ultrasound systems recalled over compatibility failures with Apple devices running iOS 18

Philips Ultrasound is recalling 4,819 Lumify Diagnostic Ultrasound Systems because compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imaging.

What this means for you

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: Scored 2 because the record cites a software compatibility failure with no stated patient consequence or reported harm.

Plain-English summary

The Philips Lumify Diagnostic Ultrasound System, models 795005, 795161 and 989605449841, is being recalled.

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imaging.

The record lists 4,819 systems, carrying UDIs 700884838103405, 00884838120266, 00884838064713 and 00884838108455, with affected serial numbers listed in the enforcement record. Distribution was worldwide, including nationwide across the United States and Puerto Rico and to a wide range of other countries. The FDA has classified the action as Class II.

The record describes a loss of live imaging function tied to a specific mobile operating system version, and states no injuries. Facilities should follow Philips' instructions.

The recalled product

Product
IntelliVue Patient Monitor MX550. Product Number: 866066.
Manufacturer
Philips North America Llc
Category
Medical Device — Ultrasound system
Hazard
  • software-compatibility
  • imaging-failure
  • ios-18

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 (3)

  • Product Number: 866066
  • UDI-DI: 00884838038783
  • All Serial No.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category