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PHILIPS HEADQUARTERS CAMBRIDGE recalls Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
Recalled May 31, 2023 · FDA recall Z-1622-2023 · PHILIPS HEADQUARTERS CAMBRIDGE
Hazard
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 · FDA Class II
Units
7 units US and 76 unit OUS
Sold at
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
Description
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
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
Manufacturer(s)
PHILIPS HEADQUARTERS CAMBRIDGE
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →