The Recall Desk
HighFDA (Devices)·Z-1623-2023·Announced 2023-05-31

Philips Incisive CT System Recalled for Potential Image Orientation Error

Philips recalls the Incisive CT whole-body X-Ray imaging system in 22 units due to potential incorrect image orientation that could result in flipped or reversed images, leading to misdiagnosis, incorrect treatment, or unnecessary radiation exposure.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall where no illnesses or injuries have been reported. However, the potential for incorrect image orientation could lead to serious patient harm through misdiagnosis or incorrect treatment. Per the rubric, risk-of-harm products where injury has not yet been reported score as High.

Plain-English summary

Philips Headquarters Cambridge is recalling the Incisive CT whole-body computed tomography (CT) X-Ray System, Model Number 728143 for use outside the United States (OUS). A total of 22 units are affected by this recall.

The system has a potential for incorrect image orientation, which may result in images being flipped or reversed. This defect could lead to misdiagnosis, incorrect treatment of a condition, or the need for a rescan that would result in additional radiation exposure to the patient.

The affected devices were distributed to healthcare facilities in Arkansas, California, Oklahoma, and Texas, as well as internationally to Argentina, Australia, Austria, China, Colombia, Czech Republic, Dominican Republic, France, Germany, Guadeloupe, Hong Kong, India, Japan, Kuwait, Latvia, Lithuania, Netherlands, Norway, Portugal, Romania, Spain, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam. The specific serial numbers of affected units are: 75592542, 81629039, 82435668, 84375501, 85146962, 85469672, 86188405, 86188817, 86820074, 87367597, 92174932, 92622328, 92637836, 92680372, 92823844, 92870027, 92889235, 94581069, 95050209, 95055576, 96094114, and 96462378.

Healthcare facilities that have received this system should contact Philips Headquarters Cambridge immediately to verify whether their units are affected by checking the serial number. Affected users should discontinue use of their devices pending instructions from the manufacturer regarding correction of the image orientation issue.

The recalled product

Product
Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
Manufacturer
PHILIPS HEADQUARTERS CAMBRIDGE
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
22

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 4 recalled by PHILIPS HEADQUARTERS CAMBRIDGE under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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Same hazard · image orientation error

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