IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Reported: May 14, 2025 Initiated: April 7, 2025 #Z-1740-2025
Product Description
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Reason for Recall
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.
Details
- Recalling Firm
- Philips Medical Systems Nederland B.V.
- Units Affected
- 996 units (267 US, 729 OUS)
- Distribution
- Domestic: Nationwide Distribution International: Australia, Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Luxembourg, Mexico, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
- Location
- Eindhoven, N/A
Frequently Asked Questions
What product was recalled? ▼
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.. Recalled by Philips Medical Systems Nederland B.V.. Units affected: 996 units (267 US, 729 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 14, 2025. Severity: Moderate. Recall number: Z-1740-2025.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11