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Philips North America Recall 93362

Description: Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Philips North America Recall 93362 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0319-2024
Event ID93362
Event DescriptionSpectral CT on Rails, Software Version 5.1.0, Model Number 728334
Product TypeDevices
DistributionUS Nationwide distribution in the state of MN.
Quantity1 unit
Recall ReasonThis recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).
Device Classification20231122
Device Code InfoUDI-DI: 00884838103627; Lot Code: 1005
Center Classification Date20231116
Recall Initiation Date20231009
Recalling FirmPhilips North America
Initial Notification Letter
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