Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Summary
The FDA issued a Class II for Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 by Philips North America. Reason: This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scan.
Details
Source
Device Recall
External ID
Z-0319-2024
Action Date
2023-11-22
Status
Ongoing
Category
device
Product Description
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Lot/Code Info: UDI-DI: 00884838103627; Lot Code: 1005
Quantity Affected: 1 unit
Reason for Recall
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).
Distribution
US Nationwide distribution in the state of MN.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-09
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 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America has 126 FDA actions in our database, including 126 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 North America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America have FDA actions?
Philips North America has 126 FDA actions in our database, including 126 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0319-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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