PHILIPS HEADQUARTERS CAMBRIDGE: Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)

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

Details from the source

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 Quantity: 22 units Lot/code info: 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

UPC codes

00884838085015

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.