Philips North America Llc: Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

Hazard

Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

Details from the source

Reason for recall: Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient. Distribution: Worldwide distribution: US (Nationwide); and OUS (Foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Czech Republic, Estonia, France, Germany, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Lebanon, Libya, Luxembourg, Mauritius, Mexico, Monaco, Morocco, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Ph Quantity: 630 units Lot/code info: Model No. 728242, 728243, 728244; UDI: (01)00884838098725(21)7014, (01)00884838098725(21)7032, (01)00884838059450(21)7056, (01)00884838098725(21)7060, (01)00884838098725(21)7062, (01)00884838098725(21)7064, (01)00884838098725(21)7072, (01)00884838098725(21)7087, (01)00884838059450(21)7096, (01)00884838059450(21)7123, (01)00884838059450(21)7124, (01)00884838098725(21)7128, (01)00884838098725(21)7135, (01)00884838098725(21)7154, (01)00884838098725(21)7163, (01)00884838098725(21)7179, (01)00884838098725(21)7191, (01)00884838098725(21)7220, (01)00884838098725(21)7221, (01)00884838098725(21)7229, (01)00884838059450(21)7240, (01)00884838098725(21)7245, (01)00884838098725(21)7246, (01)00884838098725(21)7247, (01)00884838098725(21)7254, (01)00884838098725(21)7256, (01)00884838098725(21)7282, (01)00884838098725(21)7283, (01)00884838098725(21)7292, (01)00884838098725(21)7297, (01)00884838098725(21)7304, (01)00884838098725(21)7306, (01)00884838098725(21)7309, (01)00884838098725(21)7311, (01)00884838098725(21)7331, (01)00884838098725(21)7332, (01)00884838059450(21)7333, (01)00845225003036(10)0302624730(21)7336, (01)00845225003036(10)0302624730(21)7341, (01)00845225003036(10)0302624730(21)7345, (01)00845225003036(10)0302624730(21)7348, (01)00845225003036(10)0302624730(21)7353, (01)00884838059450(21)7355, (01)00884838059450(21)7362, (01)00845225003036(10)0302624730(21)7364, (01)00845225003036(10)0302624730(21)7367, (01)00845225003036(10)0302624730(21)7373, (01)00884838098725(21)7396, (01)0

UPC codes

00884838098725, 00884838059450, 00845225003036, 00884838095168, 00845225003050, 00884838101142, 00845225003043

Source

Official record: FDA (Device enforcement) ↗

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