The Recall Desk
HighFDA (Devices)·Z-1827-2024·Announced 2024-05-22

Philips Patient Information Center iX Software: Event Catalog Data Loss Recall

Philips Patient Information Center iX software version 4.x fails to properly save or transfer event catalog information, risking data loss in healthcare facilities. The FDA issued a Class II recall affecting 358 units globally.

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 medical device software recall. Event Catalog data loss could compromise patient care information access. While no incidents are reported, the defect poses a risk of harm in clinical decision-making settings.

Plain-English summary

Philips North America LLC is recalling Patient Information Center iX and Patient Information Center iX Expand software, version 4.x (models 866389 and 866390). The software is used in patient information management systems in healthcare facilities.

The defect: Event Catalog information does not save when copied and transferred between units. This failure results in loss of patient event data.

Distribution: 358 units worldwide have been affected—45 in the United States (CA, FL, GA, IA, MA, MI, MN, MO, NJ, NM, NY, OH, PA, TN, TX, WA, WV, and DC) and 313 internationally (AE, AT, AU, BE, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IE, IL, IN, IT, JP, KR, LT, NL, NO, OM, PL, PT, RO, SE, SG, SK, TH, and ZA).

The FDA issued this Class II recall (Z-1827-2024). Healthcare facilities operating affected software versions should take appropriate steps to verify data integrity and contact the manufacturer for remediation guidance.

The recalled product

Product
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
Manufacturer
Philips North America Llc
Category
Medical Device — Clinical Software / Patient Information System
Hazard
  • data-loss
  • software-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 No. 866389 and 866390. UDI-DI: n/a
  • Serial No. 7G6G-7PGV-W
  • 5971-2NL7-Z
  • 6D62-19MD-9
  • 463N-67ME-X
  • 6U1W-7TJA-9
  • 5K2A-6DHP-K
  • 5E42-35J4-P
  • 4E6Z-70HU-B
  • 1T12-0MNA-C
  • 0C0L-0FKE-4
  • 2H34-3MMP-U
  • 6P1E-7HJU-W
  • 3R6X-3XNY-6
  • 7F50-53NK-L
  • 3Z3B-1AHM-H
  • 0128-2WG5-0
  • 0K6E-39G4-5
  • 0C5Y-7FHX-V
  • 0X7R-2AGC-Y

Distribution

Distributed nationwide across the United States.

Related recalls

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