FDA Medical devices recall ·
Philips IntelliSpace Cardiovascular software, Model 830089 recall
- Recall number
- Z-1252-2025
- Date
- (initiated April 4, 2024)
- Company / brand
- Philips Medical Systems Nederland B.V.
High Tech Campus 36, Eindhoven, Netherlands - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 139
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Philips IntelliSpace Cardiovascular software, Model 830089.
Why was it recalled?
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.
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.
States: Alaska Alabama Arizona California Connecticut Florida Georgia Iowa Indiana Kentucky Massachusetts Michigan Minnesota North Carolina Nebraska New York Ohio Oregon Tennessee Texas Virginia Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1252-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.