Summary
The FDA issued a Class II for Incisive CT, software version 5.0 by Philips Healthcare. Reason: Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan ma.
Details
Source
Device Recall
External ID
Z-2520-2023
Action Date
2023-10-11
Status
Ongoing
Category
device
Product Description
Incisive CT, software version 5.0
Lot/Code Info: software version 5.0
Quantity Affected: 140 systems
Reason for Recall
Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm.
Distribution
US Nationwide Distribution
Type: FDA Mandated
Recall Initiated: 2023-08-02
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips Healthcare has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Healthcare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Healthcare have FDA actions?
Philips Healthcare has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2520-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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