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IntelliSpace Cardiovascular recallZ-1252-2025 · Philips Medical Systems Nederland B.V. · initiated Apr 4, 2024

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

Study data is not able to be archived, copied, or exported with the cardiovascular software version.

FDA root cause category: Software design

What the company is doing

The recalling firm initially issued an "Important Product Notice" dated 3/12/2024 which their consignees received on 4/4/2024 informing them that Philips had identified an issue with the IntelliSpace Cardiovascular software version 7.0 where study data is not able to be archived, copied, or exported. The notice was to explain the issue and under what circumstances it can occur, the affected products and how to identify them, the actions the customer can take to minimize the effect of the issue, and the actions planned by Philips to correct the issue. The actions were: (1) The customer may continue to use the system in accordance with its intended use; (2) If study data cannot be archived, exported, or copied from ISCV via DICOM or to a CD, update the "Reason for Study" field using less than 64 characters; (3) Circulate the notice to all users of the system so they are aware of the issue; and (4) Retain the letter with the system until Philips has implemented the software correction. Philips will contact the customer to schedule a time for a Field Service Engineer to visit their site and install a software solution to resolve the issue. No response form was enclosed. A follow-up Urgent Medical Device Correction letter dated 1/8/2025 was issued on 1/10/2025 to the U.S. consignees who have not yet received the software correction. The letter supersedes the initial 3/12/2024 letter. The 1/8/2025 letter contains updated information with respect to the potential hazard/harm associated with the issue based on the revised Health Hazard Evaluation (HHE Rev C, 02-Jan-2025). The letter also had a response form attached for completion and return no later than 30 days after receipt of the letter.

Recall details

Recall number
Z-1252-2025
Status
Open, Classified
Initiated by the company
Apr 4, 2024
Posted by the FDA
Feb 28, 2025
Recalling firm
Philips Medical Systems Nederland B.V.
Quantity
139
Product code
LLZ
FDA submissions
K153022
Distribution
US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA, IN, KY, MA, MI, MN, NC, NE, NY, OH, OR, TN, TX, VA, and WI. There was government distribution but no military distribution.

Product description

Philips IntelliSpace Cardiovascular software, Model 830089.

Code information (models, lots, serial numbers)

Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.

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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