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.
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: 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
- Affected units
- 1,913,441
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.
Part of a larger recall action
This product is one of 22 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.
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