Patient information centers recalled over a patch changing notification filters
Philips North America is recalling 146 Patient Information Center iX units because a software patch modifies Mobile Event Notification filter settings without any indication to the user.
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 silent change to notification filter settings with no stated consequence or reported harm.
Plain-English summary
The Philips Patient Information Center iX running software version 4.5.0 is being recalled by Philips North America.
The reason given in the enforcement record is that a recent software patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
The record lists 146 units, of which 41 are in the United States and 105 outside it, under model numbers 866389 and 866390, with UDI-DI and serial numbers recorded in the enforcement record. Distribution was worldwide, covering the United States nationwide and the countries listed in the record. The FDA has classified the action as Class II.
The record names no further consequence and reports no injuries. Facilities should follow Philips' instructions, including any guidance on checking notification filter settings after an upgrade.
The recalled product
- Product
- Patient Information Center iX; Software Version Number: 4.5.0
- Manufacturer
- Philips North America
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) 866389
- (2) 866390
- UDI-DI: (1) 00884838127074
- (2) N/A
- Serial Numbers: 4Z24-5CKL-P
- 0P6C-4TL3-D
- 6J58-3LL6-0
- 216G-7PGV-E
- 0F2U-1BLC-H
- 291E-7HJU-A
- 1M6W-1UP5-1
- 4620-0XNW-5
- 4W5R-3FHA-L
- 6B73-3ZKP-K
- 3E79-49M4-3
- 4F6Y-70HU-P
- 0128-2WG5-0
- 0830-3RLW-W
- 097K-7LPC-5
- 0D2V-1BLC-8
Distribution
Distributed nationwide across the United States.
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