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IntelliSpace Cardiovascular recallZ-2543-2025 · Philips Medical Systems Nederland B.V. · initiated Aug 8, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Medical Systems Nederland B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Software issue that results in the display of outdated information.

FDA root cause category: Software design

What the company is doing

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 [email protected]. 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).

Recall details

Recall number
Z-2543-2025
Status
Open, Classified
Initiated by the company
Aug 8, 2025
Posted by the FDA
Sep 9, 2025
Recalling firm
Philips Medical Systems Nederland B.V.
Quantity
4 units
Product code
LLZ
FDA submissions
K153022
Distribution
US Nationwide distribution in the states of GA, NC & TX.

Product description

IntelliSpace Cardiovascular, Software 8.0.0.4.

Code information (models, lots, serial numbers)

Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

8 devices cleared under K153022 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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