Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
Summary
The FDA issued a Class II for Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Numbe by PHILIPS HEADQUARTERS CAMBRIDGE. Reason: Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or a.
Details
Source
Device Recall
External ID
Z-1625-2023
Action Date
2023-05-31
Status
Ongoing
Category
device
Product Description
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
Lot/Code Info: UDI-DI: (01)00884838103474(21) Serial Number: 530537 554032 554060 554065 554078
Quantity Affected: 5 units
Reason for Recall
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
Distribution
AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-12
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 141 device recalls issued in the same week, part of 403 device-related FDA actions this month.
PHILIPS HEADQUARTERS CAMBRIDGE has 4 FDA actions in our database, including 4 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 HEADQUARTERS CAMBRIDGE) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHILIPS HEADQUARTERS CAMBRIDGE have FDA actions?
PHILIPS HEADQUARTERS CAMBRIDGE has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1625-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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