The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1926-2024·Announced 2024-06-05

Philips Hemodynamic Application software pressure wave data synchronization defect

Philips Interventional Hemodynamic Application software versions 1.2.0–1.3.1 may not correctly synchronize pressure wave data when acquiring measurements from two devices simultaneously.

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 3/5 (High).

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: FDA Class II classification for a software data synchronization defect affecting hemodynamic measurements used in invasive cardiac and vascular procedures. No illnesses or injuries have been reported, but the defect poses a risk of harm through potentially inaccurate clinical data.

Plain-English summary

Philips Medical Systems is recalling Interventional Hemodynamic Application software (versions 1.2.0, 1.2.1, 1.2.2, 1.2.3, 1.3.0, and 1.3.1) used during invasive cardiac and vascular procedures to obtain hemodynamic data.

The software may not correctly synchronize pressure wave data when acquiring measurements from two devices at the same time. This synchronization defect could result in inaccurate hemodynamic data being reported to clinicians.

Approximately 391 units of the affected software have been distributed worldwide. Within the United States, affected installations are located in California, Indiana, and Oregon. The software was also distributed to healthcare facilities in approximately 30 additional countries.

Healthcare facilities using the affected software versions should contact Philips Medical Systems for instructions on remediation and software updates.

The recalled product

Product
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Hemodynamic Monitoring Software
Hazard
Affected units
391

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)

  • Software Versions 1.2.0
  • 1.2.1
  • 1.2.2
  • 1.2.3
  • 1.3.0
  • 1.3.1. Model No. 722467
  • UDI: (01)00884838100084 (11)200826(10)5.2.0.0
  • (01)00884838101180(21)616
  • (01)00884838101180(21)349
  • (01)00884838101180(21)2111600488
  • (01)00884838101180(21)2111601116
  • (01)00884838101180(21)482
  • (01)00884838101180(21)412
  • (01)00884838101180(21)2111601659
  • (01)00884838101180(21)2111601041
  • (01)00884838101180(21)2111601582
  • (01)00884838101180(21)251
  • (01)00884838101180(21)934
  • (01)00884838101180(21)305
  • (01)00884838101180(21)295

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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