CLASS II ONGOING Device recall · Reported 31 May 2023 · FDA Enforcement Report
Incisive CT- whole-body computed tomography (CT) X-Ray System recalled
Philips Headquarters Cambridge is recalling Incisive CT- whole-body computed tomography (CT) X-Ray System, distributed in Arkansas, California, Oklahoma, Texas. The recall was initiated on 12 Apr 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1622-2023
- FDA event ID
- 92238
- Recalling firm
- Philips Headquarters Cambridge, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Apr 2023
- FDA classified
- 23 May 2023
- Reported
- 31 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 12 Apr 2023 | Recall initiated by company | |
| 23 May 2023 | Classified by FDA | +41 days |
| 31 May 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
Where it was distributed
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
Questions about this recall
Why was it recalled?
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
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 92238| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Incisive CT- Whole-body computed tomography (CT) X-Ray System recalled | Philips Headquarters Cambridge | Other | 4 states | |
| CLASS II | Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System recalled | Philips Headquarters Cambridge | Other | 4 states | |
| CLASS II | Incisive CT Power- Whole-body computed tomography (CT) X-Ray System recalled | Philips Headquarters Cambridge | Other | 4 states |
More recalls from Philips Headquarters Cambridge
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Incisive CT Power- Whole-body computed tomography (CT) X-Ray System recalled | Philips Headquarters Cambridge | Other | 4 states |
| Device | CLASS II | Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System recalled | Philips Headquarters Cambridge | Other | 4 states |
| Device | CLASS II | Incisive CT- Whole-body computed tomography (CT) X-Ray System recalled | Philips Headquarters Cambridge | Other | 4 states |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |