Philips IntelliSpace Cardiovascular software recall: Software Issue
Philips IntelliSpace Cardiovascular software, Model 830089.
Why was Philips IntelliSpace Cardiovascular software recalled?
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.
- Product
- Philips IntelliSpace Cardiovascular software, Model 830089.
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Quantity
- 139
- 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.
- Recall date
- March 12, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)