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Philips North America Recall 93773

Description: ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150

Philips North America Recall 93773 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1073-2024
Event ID93773
Event DescriptionProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
Product TypeDevices
DistributionNationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand
Quantity20 units
Recall ReasonIssue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)
Device Classification20240221
Device Code InfoUDI: N/A Serial Numbers US: 4 5 6 7 8 9 11 12 13 14 17 18 61 692222229 692222254 692222263 Serial Numbers OUS: 53 56 65 692222227
Center Classification Date20240209
Recall Initiation Date20231215
Recalling FirmPhilips North America
Initial Notification Letter
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