FDA Medical Device Recalls (openFDA)
Philips Medical Systems Nederland B.V.: IntelliSpace Cardiovascular, Software 8.0.0.4.
- Recall number
- Z-2543-2025
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Product
- IntelliSpace Cardiovascular, Software 8.0.0.4.
- Status
- Open, Classified
- Initiated
- 2025-08-08
- Posted
- 2025-09-09
- Terminated
- not on file
- Reason
- Software issue that results in the display of outdated information.
- Root cause
- Software design
- Action
- An URGENT Medical Device Correction notice dated 8/7/25 was mailed to consignees. The notification includes instructions for continued safe use of devices, which includes: 1. Ensure all finding codes with variables/modifiers are populated correctly on the report screen. Do not leave any FitB Modifier Code Fields Blank. 2. Verify report statements match the selections in the work area before finalizing report. Systems may continue to be used in accordance with the intended use and per the additional instructions. The provided recall notification is to be shared with all users of the device and retained with affected systems until the corrected software is installed. The provided recall response form should be returned within 30 days to Philips.recall@Philips.com. A Philips representative will call consignees to schedule a time to install the software solution (FCO83000218). Consignees with any questions can contact Philips Informatics Customer Support at 1-800-996-1328 (x1).
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of GA, NC & TX.
- Lot, serial or model codes
- Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
- 510(k) numbers
- ["K153022"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3000976525
- Firm city
- Eindhoven
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28