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-1623-2023
- 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: 728143 (OUS)
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)00884838085015(21) Serial Numbers: 75592542 81629039 82435668 84375501 85146962 85469672 86188405 86188817 86820074 87367597 92174932 92622328 92637836 92680372 92823844 92870027 92889235 94581069 95050209 95055576 96094114 96462378 Serial Numbers: 75592542 81629039 82435668 84375501 85146962 85469672 86188405 86188817 86820074 87367597 92174932 92622328 92637836 92680372 92823844 92870027 92889235 94581069 95050209 95055576 96094114 96462378
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 92238This product is part of a recall event; the main page for the event is Incisive CT- whole-body computed tomography (CT) X-Ray System recalled.
| 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 |
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