The Recall Desk
HighFDA (Devices)·Z-1740-2025·Announced 2025-05-14

[pending] IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

Pending LLM rewrite. Source: FDA_DEVICE Z-1740-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.

The recalled product

Product
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Manufacturer
Philips Medical Systems Nederland B.V.
Category
Medical Device — Devices

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 (9)

  • Model Number: 830089
  • Software Versions: 6x
  • 7.x
  • and 8.x
  • UDI-DIs: (01)00884838106970(11)211130(10)6.1.0.0 (Version 6.1.0.0)
  • (01)00884838106970(11)220623(10)6.2.0.0 (Version 6.2.0.0)
  • (01)00884838115378(11)221214(10)7.0.0.0 (Version 7.0.0.0)
  • (01)00884838115378(11)230711(10)7.1.0.0 (Version 7.1.0.0)
  • (01)00884838122000(11)240325(10)8.0.0.0 (Version 8.0.0.0).

Distribution

Distributed nationwide across the United States.

Related recalls

Same category