Quick Facts at a Glance
- Recall Date
- August 8, 2025
- Hazard Level
- HIGH
- Brand
- Philips Medical Systems Nederland B.V.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Philips Medical Systems Nederland B.V.
- Product type
- Medical Device Software
- Model numbers
- Model No. 830089, UDI: (01)00884838122000(11)240325(10)8.0.0.0, Serial No. 2210, Serial No. 2050, Serial No. 463, Serial No. 193
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 8, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Software issue that results in the display of outdated information.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for instructions. Notification method: Letter
About This Product
IntelliSpace Cardiovascular is a hospital information system used to manage cardiovascular imaging and patient data. It helps clinicians track studies and patient information across workflows.
Why This Is Dangerous
The defect can cause the display to show information that is not current, potentially impacting clinical decisions.
Industry Context
No information indicates a broader industry pattern.
Real-World Impact
Hospitals may experience workflow disruption and potential misinterpretation of patient data until the software is updated or replaced.
Practical Guidance
How to identify if yours is affected
- Verify device model No. 830089 and software version 8.0.0.4.
- Check serial numbers 2210, 2050, 463, 193 against the recall list.
- Confirm the device was distributed in GA, NC, TX.
Where to find product info
Model number and software version appear on the device label and within the software interface. Serial numbers are on the device hardware.
What timeline to expect
Recall remedies and updated software will be issued by Philips; no timeline is provided in the notice.
If the manufacturer is unresponsive
- Document all communication attempts with Philips.
- Engage hospital risk management and procurement.
- If access is blocked, contact FDA for guidance.
How to prevent similar issues
- Register hardware with the vendor for recall notices.
- Establish a procedure to halt use of affected devices upon recall.
- Maintain an up-to-date inventory of cardiovascular devices and software versions.
Documentation advice
Keep copies of the recall notice, device IDs, serial numbers, and all correspondence with Philips and healthcare providers.
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Product Details
Model No. 830089 UDI: (01)00884838122000(11)240325(10)8.0.0.0 Serial Numbers: 2210, 2050, 463, 193 Distribution: US nationwide in GA, NC, TX Sold to: Healthcare facilities via distributors (no consumer retailer listed) Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- States affected: GA, NC, TX
- Manufacturer: Philips Medical Systems Nederland B.V.
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Safety Guide
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