Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
Summary
The FDA issued a Class II for Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728 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-1622-2023
Action Date
2023-05-31
Status
Ongoing
Category
device
Product Description
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
Lot/Code Info: UDI-Di: (01)00884838105508(21) Serial Numbers: 34053, 34092, 34164, 34168, 34179, 34195, 34200 (US) OUS: System Serial Number 34010 34020 34061 34070 34107 34108 34127 34142 34147 34157 34158 34161 34166 34176 34177 34178 34180 34194 34202 500453 500499 500501 500504 500506 500508 500511 500518 500529 550004 550023 550025 550034 550041 550052 550065 550069 550077 550079 550084 550086 550093 550103 550107 550114 550115 550119 550121 550128 550130 550140 550141 550150 550162 550164 550169 550174 550176 550181 550187 550188 550191 550194 550195 550203 550212 550234 550241 550248 550249 550251 550256 550266 550270 552038 552040 554023
Quantity Affected: 7 units US and 76 unit OUS
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-1622-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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