Quick Facts at a Glance
- Recall Date
- November 26, 2025
- Hazard Level
- HIGH
- Brand
- Philips
- 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
- Product type
- Patient Monitor
- Model numbers
- 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 01-2017
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 26, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Remote Diagnostic Technologies Ltd. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Philips Tempus Pro Patient Monitor is designed for monitoring vital signs, including intracranial pressure and bladder pressure in medical settings. Healthcare providers use it to make critical decisions for patient care.
Why This Is Dangerous
The monitor's measurements for ICP and BDR have not been tested for accuracy. This lack of validation poses a risk of incorrect clinical decisions if healthcare providers rely on these readings.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers relying on the monitor for patient assessments. The urgency for action is high as incorrect measurements can lead to serious health implications.
Practical Guidance
How to identify if yours is affected
- Check the model number and reference numbers on the device.
- Verify the serial number against the list provided in the recall notice.
- Review the user manual for additional identification details.
Where to find product info
Model numbers and serial numbers are typically found on the back or bottom of the monitor, as well as in the user manual.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements after following the recall instructions.
If the manufacturer is unresponsive
- Document all communications with the company.
- Reach out to relevant consumer protection agencies.
- Consider seeking legal advice if necessary.
How to prevent similar issues
- Look for devices with validated measurements and certifications.
- Check for safety recalls before purchasing medical devices.
- Consult with healthcare professionals regarding device reliability.
Documentation advice
Keep copies of all correspondence regarding the recall, including receipts, emails, and any notifications from the manufacturer.
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Product Details
The recalled models include REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, and USB 2-Channel IBP Module REF: 01-2017. These devices were distributed worldwide, including states like AZ, CA, TX, and FL.
Key Facts
- Quantity recalled: 7,129 units
- Potential hazard: Inaccurate clinical measurements
- Immediate action required: Stop using the device
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Safety Guide
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